Clinical UM Guideline

This document addresses biofeedback, a treatment that provides an individual with information about physiological processes that are normally involuntary, such as blood pressure, muscle tension, and heart rate. The individual then uses this information to gain voluntary control and modify those processes. Examples of biofeedback techniques include thermal biofeedback, where the individual is provided information on skin temperature, and electromyographic (EMG) biofeedback, where the individual is provided information on muscle tension.

Neurofeedback, also known as electroencephalogram (EEG) biofeedback, is a type of biofeedback that uses EEGs as the feedback source. EEG information is signaled to the individual, usually by video or sound, to train the individual to self-regulate brain activity. Neurofeedback is being studied for a variety of medical and psychological conditions.

Note: Neurofeedback (EEG biofeedback) should not be confused with electroencephalograms (EEGs) used for the diagnosis of neurological disorders.

Note: Please see the following related document for additional information:

• MED.00138 Wearable Devices for Stress Relief and Management

Note: Please see the following document which addresses surface electromyography (sEMG) such as the SPEAC sEMG activity alert system:

• MED.00130 Surface Electromyography and Electrodermal Activity Sensor Devices for Seizure Monitoring

Note: For a high-level overview of this document, please see "Summary for Members and Families" below.

Medically Necessary:

Biofeedback therapy is considered medically necessary when the following criteria are met:

1. Supervised by a physician or licensed practitioner; and
2. Used as treatment for at least one of the following conditions:
   1. Cancer pain; or
   2. Chronic back pain as part of a rehabilitation program; or
   3. Chronic constipation; or
   4. Fecal incontinence; or
   5. Levator ani syndrome, also known as anorectal pain syndrome; or
   6. Migraine or tension headaches; or
   7. Urinary incontinence.

Not Medically Necessary:

Biofeedback therapy is considered not medically necessary when the criteria above are not met, and for all other indications.

Neurofeedback, also known as electroencephalogram (EEG) biofeedback, is considered not medically necessary for all indications, including but not limited to:

1. Asthma;
2. Attention-deficit/hyperactivity disorder;
3. Autism spectrum disorders;
4. Cardiovascular conditions;
5. Cluster headaches;
6. Epilepsy;
7. Post-traumatic stress disorder;
8. Substance use disorders;
9. Traumatic brain injury.

The use of home biofeedback devices is considered not medically necessary for all indications.

This document describes clinical studies and expert recommendations, and explains when biofeedback and neurofeedback are clinically appropriate. The following summary does not replace the medical necessity criteria or other information in this document. The summary may not contain all of the relevant criteria or information. This summary is not medical advice. Please check with your healthcare provider for any advice about your health.

Key Information

Biofeedback is a type of training that uses sensors on the body to show people how their muscles, heart rate, or other body functions are working. A trained provider uses this information to help people learn to control these body functions. The goal is to reduce symptoms of certain health conditions.

Neurofeedback is a specific type of biofeedback that measures brain wave activity. Sensors are placed on the head to track brain signals. The person then tries to change their brain wave patterns based on what they see or hear.

There are many types of biofeedback devices. Some measure muscle activity. Others measure heart rate, skin temperature, or breathing. These devices are used in a provider's office or at home as part of a treatment plan.

What the Studies Show

Studies show that biofeedback can help people who have trouble controlling their bladder or bowel. When combined with pelvic floor exercises, biofeedback can help people learn to use the right muscles to prevent leakage of urine or stool. Multiple reviews of studies found that this approach can reduce leaking and improve quality of life.

For long-term constipation caused by muscles that do not work together the right way during a bowel movement, studies found that biofeedback can help people retrain those muscles. Expert groups recommend biofeedback for this condition.

For migraines and tension headaches, studies show that biofeedback can reduce how often headaches happen and how bad they feel. It may also help people use less headache medicine. Expert groups have found that biofeedback works well as a way to help prevent migraines.

For chronic low back pain, studies found that biofeedback, when used as part of a rehabilitation program, can help reduce pain. The benefits can last for several years.

For neurofeedback, the results are less clear. Studies on neurofeedback for attention problems (ADHD)attention-deficit/hyperactivity disorder (ADHD) in children show that both real and pretend (sham) neurofeedback led to similar results. This means better studies are needed to know if neurofeedback improves health for ADHD. For other conditions, such as anxiety, post-traumatic stress disorder, and substance use disorders, studies have been too limited to draw clear conclusions on how well they work.

Home biofeedback devices have been studied, but there is not enough evidence to show they work as well as biofeedback done in a provider's office.

When Is Biofeedback Clinically Appropriate?

Biofeedback may be clinically appropriate in these situations:

• The treatment is supervised by a physician or licensed practitioner; and
• It is used for one of the following conditions:
  • Cancer pain; or
  • Chronic back pain as part of a rehabilitation program; or
  • Chronic constipation; or
  • Fecal incontinence; or
  • Levator ani syndrome, also called anorectal pain syndrome; or
  • Migraine or tension headaches; or
  • Urinary incontinence.

When Is This Not Clinically Appropriate?

Biofeedback is not clinically appropriate when the conditions above are not present.

Neurofeedback is not clinically appropriate for any condition, including asthma, attention-deficit hyperactivityattention-deficit/hyperactivity disorder, autism spectrum disorders, heart and blood vessel conditions, cluster headaches, epilepsy, post-traumatic stress disorder, substance use disorders, or traumatic brain injury. Studies show that neurofeedback does not work better than comparison treatments, with both groups often improving the same amount. Studies show that neurofeedback does not work better than comparison treatments; participants receiving neurofeedback and those receiving comparison treatments often improve to a similar degree.

Home biofeedback devices are also not clinically appropriate for any condition. Studies have not clearly shown that home use of these devices works as well as supervised treatment.

(Return to Description)

The following codes for treatments and procedures applicable to this guideline are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

Perineal biofeedback
When services are Medically Necessary:

When services are Not Medically Necessary:
For the procedure codes listed above for all other diagnoses not listed.

Other biofeedback (EMG, thermal, heart variability, galvanic skin response)
When services are Medically Necessary for biofeedback techniques other than EEG biofeedback or neurofeedback:

When services are Not Medically Necessary:
For the procedure codes listed above for all other diagnoses not listed, or when the code describes a procedure indicated in the Clinical Indications section as not medically necessary.

Neurofeedback (EEG biofeedback) and home devices
When services are Not Medically Necessary:

Summary

Biofeedback for covered indications is supported by moderate- to high-certainty evidence from systematic reviews and randomized controlled trials, with the strongest evidence base for urinary incontinence, fecal incontinence, and headache. Multiple professional society guidelines support biofeedback as a conservative therapy option for pelvic floor dysfunction and migraine prevention. Neurofeedback (electroencephalography [EEG] biofeedback) has not demonstrated consistent superiority over sham or active control conditions in adequately powered trials. Home biofeedback devices remain an area of active investigation, but current evidence does not establish their equivalence to supervised, office-based therapy.

Discussion

Biofeedback

Biofeedback is a training program in which an individual is given information about physiological processes through electronic monitoring, with the goal of influencing those processes through conscious control. Examples of such physiologic processes include heart rate, blood pressure, and muscle tension. The theory of biofeedback is that, by controlling the physiologic processes associated with a disorder, an individual can learn to control the disorder. Different types of biofeedback are used depending on the individual's symptoms or condition. Examples of different biofeedback methods include electromyography (EMG), thermal, heart rate variability, and galvanic skin response.

Migraine and Tension-Type Headache

Biofeedback is associated with reduced headache pain and decreased migraine medication use compared with relaxation therapy alone. Randomized controlled trials (RCTs) and systematic reviews in adults and children with migraine or tension-type headache support these benefits (Nestoriuc, 2007; Nestoriuc, 2008; Palermo, 2010; Scharff, 2002; Stubberud, 2016; Trautmann, 2006; Vasudeva, 2003).

Biofeedback for Urinary Incontinence

Biofeedback for the treatment of urinary incontinence usually involves placing a pressure sensor in the vagina. The sensor provides the individual with information about the strength of pelvic floor contraction. This can help individuals perform effective pelvic floor muscle training (PFMT) exercises. PFMT exercises are also called Kegel exercises.

The evidence supporting biofeedback therapy in the treatment of urinary incontinence for adults and children includes RCTs (Burgio, 2002; Burgio, 2006; Hagen, 2020a; Klijn, 2006; Sahin, 2022; Sam, 2022) and systematic reviews (Fitz, 2012; Hsu, 2016; Johnson, 2023; Nunes, 2019). Conclusions of individual RCTs were mixed. For example, Hagen and colleagues (2020a; 2020b) did not find a significant benefit of biofeedback plus PFMT at 24 months compared with PFMT alone. However, systematic reviews and clinical guidelines are generally supportive of offering biofeedback as an option in individuals with urinary incontinence.

A 2021 systematic review and meta-analysis evaluated the effectiveness of combining electromyographic biofeedback (EMG-BF) with PFMT compared to PFMT alone for managing stress urinary incontinence and pelvic floor dysfunction (Wu, 2021). The meta-analysis included 21 studies with a total of 3865 individuals. Results showed that the addition of EMG-BF significantly improved cure and improvement rates for stress urinary incontinence (odds ratio [OR], 4.82; p<0.001) and pelvic floor dysfunction (OR, 2.81; p<0.001). EMG-BF combined with PFMT also enhanced pelvic floor muscle strength (standardized mean difference [SMD], 1.72; p<0.001) and improved quality of life and sexual function scores. Study limitations included high heterogeneity among studies and an overrepresentation of studies conducted in China, highlighting the need for further randomized controlled trials in diverse populations.

Fecal Incontinence, Constipation, and Anorectal Disorders

Biofeedback has demonstrated benefit across several anorectal conditions, with the strongest evidence for dyssynergic defecation. A systematic review of randomized controlled trials (RCTs) in individuals meeting the Rome criteria for dyssynergic defecation identified 11 trials with 725 participants (Moore, 2020). Despite substantial heterogeneity, a pooled analysis of 6 RCTs found biofeedback had a significantly greater benefit on global clinical improvement compared with control interventions (odds ratio [OR], 3.63; 95% confidence interval [CI], 1.10 to 11.93; p=0.03).

For chronic constipation, a systematic review of 17 RCTs (total n=931) found that supervised computer-assisted biofeedback was superior to sedatives, shams, laxatives, and lifestyle changes (Woodward, 2014). Some surgical interventions were found superior but had more side effects, whereas biofeedback was not found to cause any adverse events. However, due to the low quality of the studies, including the lack of a consistent protocol and the potential for bias, the researchers were not able to make a firm recommendation for biofeedback to treat constipation; further studies were recommended. Since then, additional studies have shown benefits of biofeedback for constipation (Ba-Bai-Ke-Re, 2014; Simón, 2019).

A 2026 randomized controlled trial compared magnetoelectric biofeedback therapy (MEBFT) to conventional biofeedback therapy (BFT) in 68 women with obstructed defecation syndrome associated with rectocele (Geng, 2026). The MEBFT group achieved a significantly higher response rate (82.35% vs. 55.88%; OR 1.71; 95% CI, 1.19 to 2.46; p=0.002) and greater improvements in the Cleveland Clinic Constipation score (48.99% vs. 32.44% reduction; p<0.001) and Patient Assessment of Constipation Quality of Life (PAC-QOL) score (29.46% vs. 20.39% reduction; p<0.001). EMG measurement of fast-twitch muscle fiber recruitment improved by 100.94% in the MEBFT group compared with 28.28% in the BFT group (p<0.01).

A 2026 randomized clinical trial evaluated home-based biofeedback for fecal incontinence in 36 individuals, comparing 8-week and 16-week training durations (Patel, 2026). Both groups achieved the minimal clinically important difference in the Vaizey incontinence score (changes of -4.7 and -4.8, respectively; p=0.918), indicating that 8 weeks of home-based biofeedback provides similar improvement to 16 weeks. However; this study did not compare biofeedback with usual care, sham treatment, PFMT alone, or no treatment. Instead, it compared 8 weeks versus 16 weeks of the same intervention. Consequently, no inference can be made about inferiority or non-inferiority of home-based biofeedback compared to more standard treatments for fecal incontinence.

Chronic Back Pain

Biofeedback for chronic back pain is supported by meta-analytic evidence showing a significant effect on pain reduction that is maintained over follow-up. In a meta-analysis of 21 studies (n=1062), biofeedback was associated with a significant small to medium effect size for pain intensity reduction (Hedges' g=0.60; 95% CI, 0.44 to 0.76) that was stable with a significant small-to-large effect size (Hedges' g=0.62; 95% CI, 0.40 to 0.84) over an average of 8 months of follow-up (Sielski, 2017). The researchers also found improvement in depression, disability, muscle tension, and coping.

A 2025 report presented the 3-year follow-up of the RESTORE trial, a randomized controlled trial comparing cognitive functional therapy (CFT) alone, CFT plus movement sensor biofeedback, and usual care in 492 individuals with chronic, disabling low back pain (Hancock, 2025). At 3 years, with 312 (63%) participants retained, CFT alone produced a Roland-Morris Disability Questionnaire (RMDQ) difference of -3.5 (95% CI, -4.9 to -2.0) compared to usual care, while CFT plus biofeedback produced a difference of -4.1 (95% CI, -5.6 to -2.6). The comparison between CFT alone and CFT plus biofeedback was not significant (difference -0.6; 95% CI, -2.2 to 0.9). Pain intensity showed a similar pattern, with both CFT groups significantly outperforming usual care and without significant differences between the CFT groups.

Cancer Pain

In their guideline on adult cancer pain (Version 1.2026), the National Comprehensive Cancer Network (NCCN) recommended biofeedback as an optional component of an integrative intervention to reduce pain (2A recommendation).

Other Conditions

There is insufficient or conflicting evidence in the peer-reviewed literature comparing biofeedback to established treatment modalities (for example, pharmacotherapy or behavior therapy) to conclude that biofeedback is an effective treatment for other conditions such as cardiovascular disease (Climov, 2014), chronic ankle instability (Koldenhoven, 2021), depression (Maynart, 2021), epilepsy (Nagai, 2018; Strehl, 2014), fibromyalgia (Babu, 2007; Theadom, 2015), hypertension (Greenhalgh, 2009; Nolan, 2010; Olsson, 2010), panic disorder (Herhaus, 2022), Parkinson disease (Yakşi, 2022), Raynaud syndrome (Malenfant, 2009), rotator cuff tear (Tiryaki, 2023), subacromial pain syndrome (de Oliveira, 2022), and tinnitus (Weise, 2008).

Home-based Biofeedback for Urinary Incontinence

The evidence for home-based biofeedback devices centers on pelvic floor applications for urinary incontinence (UI). Pelvic floor muscle training (PFMT) is an established conservative intervention for UI, but the incremental value of adding device-based biofeedback in the home setting has not been shown to provide clinically meaningful benefit over PFMT alone or to establish equivalence to supervised, office-based biofeedback therapy.

A 2025 Cochrane review evaluated PFMT with feedback or biofeedback for UI in women and included 41 studies with 3483 participants (Fernandes, 2025). These studies included 33 studies with 3031 participants evaluating PFMT plus biofeedback with PFMT alone. Most studies compared PFMT with biofeedback to PFMT alone. High-certainty evidence showed little or no difference in incontinence-specific quality of life. Moderate-certainty evidence showed 0.29 fewer leakage episodes per 24 hours with biofeedback, a difference the review considered unlikely to be clinically important, and little or no difference in subjective cure or improvement. Satisfaction may increase with biofeedback, but the certainty of evidence was low and the outcomes were unblinded. Severe adverse events were not identified in studies that evaluated them. Minor events were uncommon and included symptoms such as vaginal irritation, urinary discomfort, discomfort with vaginal device use, skin lacerations, and yeast infection, with some similar events also reported in PFMT-alone groups. (Fernandes, 2025).

The Cochrane review provides the most relevant evidence context for policy interpretation. Although the included studies varied by biofeedback modality, device type, supervision, and comparator, the review found little or no clinically meaningful incremental benefit when biofeedback was added to PFMT. The review also noted that patient-reported cure, improvement, and satisfaction may be more vulnerable to bias in unblinded treatment groups than quality-of-life and leakage-frequency measures (Fernandes, 2025).

In a retrospective cohort of 265 women with stress, urgency, or mixed UI, mean Urogenital Distress Inventory, Short Form (UDI-6) scores improved by 13.90 points after 8 weeks; 62% achieved a minimal clinically important difference (MCID), and device-recorded adherence was 72% at week 4 and 66% at week 8 (Keyser, 2023). A subsequent observational study of 947 commercial users reported clinically meaningful improvement in 74% of users across UI subtypes (Hall, 2024). These observational data support feasibility and symptom improvement during use but do not establish that the device produces improvement beyond expected effects from PFMT, participant selection, regression to the mean, or other nonrandomized factors.

An open-label randomized controlled trial (RCT) randomized 299 women with stress or stress-predominant mixed UI to Leva-guided PFMT or standard home PFMT using written and audiovisual instructions (Weinstein, 2022). At 8 weeks, UDI-6 improvement was greater with Leva than with control treatment (18.8 vs. 14.7 points; p=0.01), median stress UI episodes decreased more in the Leva group, and improvement on the Patient Global Impression of Improvement (PGI-I) was more common with Leva (44.1% vs. 28.9%; odds ratio [OR], 1.94; 95% confidence interval [CI], 1.21 to 3.15). Bladder diary episode counts may be right-skewed, which supports reporting median changes. This analytic consideration does not address the main limitations of the study, including open-label treatment assignment, unblinded self-reported outcomes, and use of unsupervised home PFMT as the comparator. The trial did not compare Leva with supervised, office-based PFMT or supervised, office-based biofeedback therapy.

Planned follow-up from the same RCT reported persistent between-group differences at 12 and 24 months, although neither group was instructed to continue the assigned intervention after the initial 8-week treatment period (Weinstein, 2023; Weinstein, 2024). At 12 months, UDI-6 improvement remained statistically greater with Leva than with control treatment (mean improvement 22.7 vs. 15.9 points; between-group difference 6.8 points). When converted to the long-form Urinary Distress Inventory scale (range 0-300) used by Barber and colleagues, the improvement in both groups exceeded the 11-point minimum important difference, indicating a clinically important within-group improvement in each arm (Barber, 2009). Because home pelvic floor muscle training alone also produced a clinically important improvement, these data do not establish a clinically meaningful incremental benefit of the device over home PFMT.

Several related self-report measures were not statistically different between groups, and device-recorded adherence declined from 69% at 8 weeks to 13% at 6 months and 17% at 12 months (Weinstein, 2023). At 24 months, PGI-I improvement remained more frequent with Leva than with control treatment (35% vs. 22%; p=0.03; OR, 1.95; 95% CI, 1.08 to 3.57) (Weinstein, 2024). These findings suggest possible durability of self-reported improvement after an initial home treatment course but do not establish equivalence or superiority to supervised, office-based therapy.

A 2025 subgroup analysis in participants with more severe UI and additional pelvic floor symptoms reported greater PGI-I improvement with Leva than with control treatment (Weinstein, 2025). This analysis may help characterize individuals more likely to report improvement, but subgroup findings based primarily on self-reported outcomes are less definitive than prespecified primary trial outcomes.

A separate noninferiority RCT compared home biofeedback without pelvic floor physical therapy (PFPT) to supervised PFPT without biofeedback in 54 individuals with stress UI using a U.S. Food and Drug Administration (FDA)-cleared intravaginal pressure sensor (Barnes, 2021). Home biofeedback met noninferiority criteria for the primary quality-of-life outcome at 3 months, but the sample size was small, follow-up was short, outcomes were unblinded and self-reported, and overactive bladder symptoms improved more with PFPT. Practical limitations differed by intervention, with device usability concerns reported for home biofeedback and access limitations reported for PFPT.

Overall, home-based biofeedback for UI has a larger evidence base than home biofeedback for other indications, but the evidence does not show clinically meaningful improvement over PFMT alone or establish equivalence to supervised, office-based therapy. The Cochrane review that included studies using the Leva Pelvic Health System found little or no improvement in incontinence-specific quality of life and only a small, clinically unimportant reduction in leakage frequency when biofeedback was added to PFMT.

Neurofeedback (EEG Biofeedback)

Neurofeedback, also referred to as electroencephalogram (EEG) biofeedback, involves providing individuals with real-time feedback on their brain activity. It has been investigated as a treatment for a variety of conditions including attention-deficit/hyperactivity disorder (ADHD), anxiety disorders, panic disorders, post-traumatic stress disorder, substance use disorders, and traumatic brain injury. Although conceptually related to other forms of biofeedback, neurofeedback differs in that the feedback is a direct measure of brain wave activity. The individual may be trained to either increase or decrease the prevalence, amplitude, or frequency of specified EEG waveforms (alpha, beta, or theta waves) depending on the desired changes. The theory of neurofeedback is that certain medical and psychological disorders are associated with specific waveforms and that voluntary modulation of those waveforms can enable the individual to control the disorder.

Anxiety and Panic Disorders

An RCT explored the use of neurofeedback on negative affect and anxiety in 32 healthy, right-handed undergraduate women (Mennella, 2017). The restriction to right-handed women was based on evidence that frontal alpha asymmetry may vary by sex, though this limited the generalizability of the findings. Participants were randomized to receive neurofeedback to increase frontal alpha symmetry (treatment group, n=16) or to increase mid-frontal alpha activity (active control group, n=16). The intervention group had a greater increase in alpha asymmetry and a significant decrease in Beck Anxiety Inventory (BAI) scores pre- to post-intervention. The small sample size, short duration, reliance on self-reported outcomes, and absence of correlation between EEG changes and symptom improvement limit confidence in the findings. In addition, the study population did not include individuals with diagnosed anxiety disorders, limiting applicability to clinical populations.

Attention-Deficit/Hyperactivity Disorder (ADHD)

The evidence for neurofeedback in ADHD is characterized by a consistent pattern: effects observed against non-active controls do not hold when compared with active controls or established treatments. Several RCTs, systematic reviews, and meta-analyses have examined neurofeedback for ADHD (Micoulaud-Franchi, 2014; Roy, 2022; Van Doren, 2019; Yan, 2019).

A systematic review and meta-analysis of 10 RCTs (506 participants) found that neurofeedback had a significant benefit over non-active controls for inattention (SMD, 0.38; 95% CI, 0.14 to 0.61) and hyperactivity/impulsivity (SMD, 0.25; 95% CI, 0.01 to 0.45), but did not show benefit over active controls (Van Doren, 2019). A separate meta-analysis of 18 head-to-head RCTs comparing neurofeedback to methylphenidate (778 neurofeedback, 757 methylphenidate) found that teacher-reported outcomes favored methylphenidate for inattention (SMD=-0.49; 95% CI, -0.83 to -0.14), while parent-reported outcomes favored neurofeedback (Yan, 2019). In sensitivity analysis removing Chinese studies and unfunded studies, no significant differences between the two treatments remained. Adequately powered, blinded trials have failed to demonstrate efficacy.

A double-blind RCT of 144 children aged 7-10 with moderate-to-severe ADHD found no statistically significant difference between neurofeedback and control for the primary outcome or parent/teacher-rated inattention after 13 months (Neurofeedback Collaborative Group, 2021). The study was listed as completed on ClinicalTrials.gov with no further publications.

A 4-arm RCT of 202 children and adolescents (ages 9-17) found that working-memory training showed some improvements over neurofeedback immediately after treatment, but gains were lost by 6 months, leading the authors to conclude that "sustained effects of neurocognitive training on cognitive functioning in children and adolescents with ADHD may be limited" (Hasslinger, 2022).

A 3-arm RCT of 84 children (ages 6-12) comparing neurofeedback, behavior management, and medication found that medication showed the greatest reduction in core ADHD symptoms (Roy, 2022).

A double-blind, sham-controlled RCT of 88 boys with ADHD evaluated functional magnetic resonance imaging neurofeedback (fMRI-NF) of the inferior frontal cortex (Lam, 2022). No significant group differences were observed on the ADHD Rating Scale (ADHD-RS). The authors concluded that "study findings do not suggest that fMRI-NF is effective in improving clinical symptoms or cognition in boys with ADHD."

The American Academy of Pediatrics (AAP) clinical practice guideline listed EEG biofeedback among interventions that have "too little evidence to recommend them or have been found to have little or no benefit" for ADHD (Wolraich, 2019).

Post-Traumatic Stress Disorder (PTSD)

Evidence for neurofeedback in PTSD is preliminary, with positive signals from small, unblinded trials that lack sham controls. A systematic review of 10 studies (3 RCTs, 7 pilot/exploratory) found that all had positive findings in at least one outcome, but the evidence base consisted of a small number of trials with substantial variability (Panisch, 2020).

A separate systematic review limited to RCTs identified 4 trials; pooled analysis of 3 trials (n=92) found significantly lower self-reported PTSD symptom scores in the neurofeedback group (mean difference [MD], -2.30; 95% CI, -4.27 to -0.24), but none used a sham control, and findings were limited by small sample sizes (Steingrimsson, 2020).

Among individual trials, an RCT of 52 individuals with chronic PTSD compared neurofeedback (n=26) with a waitlist control (n=26) over 24 sessions (van der Kolk, 2016). The neurofeedback group had significantly greater improvement in Clinician-Administered PTSD Scale (CAPS) scores (p<0.001), and at 1 month post-treatment, a smaller proportion met PTSD diagnostic criteria compared with the control group (42% vs. 90%; p=0.007). The study was limited by small size, short follow-up, and use of a waitlist rather than a sham control, which does not account for placebo or nonspecific treatment effects.

A single-arm trial of 63 participants with treatment-refractory PTSD (diagnosed 10 or more years earlier) found that Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) scores decreased by an average of 13.2 points (MCID, 6 points) and PTSD Checklist for DSM-5 (PCL-5) decreased by 12.7 points (MCID, 9-12 points), with a 3-month remission rate of 31.8% (Fruchter, 2024). Scores on the Emotion Regulation Questionnaire (ERQ) and Patient Health Questionnaire (PHQ) did not improve. The investigators planned future randomized trials with sham controls; adequately powered, controlled studies with longer follow-up are needed to confirm results.

Other Neurofeedback Conditions

There is insufficient or conflicting evidence in the peer-reviewed literature comparing neurofeedback to more established treatments (for example, pharmacotherapy or behavior therapy) to conclude that neurofeedback is an effective treatment for other conditions, including, but not limited to: asthma, autism spectrum disorders (Kouijzer, 2013), cancer pain (Hetkamp, 2019), chronic pain (Roy, 2020), cluster headache, depression (Young, 2017), dyslexia (Breteler, 2010), fall prevention in older individuals (Shahrbanian, 2021), insomnia and sleep disorders (Schabus, 2017), obsessive-compulsive disorder (Deng, 2014), stroke (Dost Sürücü, 2021; Lirio-Romero, 2021; Liu, 2021; Mihara, 2021; Renton, 2017), traumatic brain injury (Elbogen, 2021), spinal cord injury (Guo, 2021), or substance use disorders (Gabrielsen, 2022; Gerchen, 2018; Scott, 2005; Sokhadze, 2008).

Clinical Practice Guidelines

Multiple professional societies have issued guidance on biofeedback for specific indications:

Headache Prevention:

• The American Headache Society (AHS) assigned Grade A evidence to biobehavioral therapies, including cognitive behavioral therapy, biofeedback, and relaxation therapies, for preventive treatment of migraine (Ailani, 2021). The AHS stated that these therapies are effective in the preventive treatment of migraine and are particularly well suited for individuals who prefer nonpharmacologic interventions, have contraindications to medications, or have significant stress.

Urinary Incontinence:

• The American College of Physicians (ACP) found that pelvic floor muscle training (PFMT) alone or in combination with bladder training or biofeedback and weight loss with exercise for obese women were effective at achieving continence and improving urinary incontinence (Qaseem, 2014).
• The American Urological Association (AUA) recommended that PFMT with or without biofeedback should be offered for stress urinary incontinence or stress-predominant mixed urinary incontinence (Kobashi, 2023).
• The American College of Obstetricians and Gynecologists (ACOG) stated that pelvic muscle exercises may be used alone or augmented with bladder training, biofeedback, or electrical stimulation, and that pelvic floor muscle exercises can be effective as a first-line treatment for stress, urgency, or mixed urinary incontinence (ACOG, 2015; reaffirmed 2018).
• The AUA/Society of Genitourinary Reconstructive Surgeons (GURS)/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction (SUFU) guideline on incontinence after prostate treatment recommended PFMT in the immediate postoperative period (Moderate Recommendation; Grade B) and as treatment for post-prostatectomy incontinence (Moderate Recommendation; Grade B), noting biofeedback is one technique within PFMT programs (Breyer, 2024).
• The AUA/SUFU guideline on overactive bladder (OAB) classified biofeedback as a noninvasive therapy option (Clinical Principle) but noted biofeedback "does not appear to confer additional benefit in patients with OAB undergoing PFMT except in select groups" (Cameron, 2024).

Constipation, Fecal Incontinence, and Anorectal Disorders:

• The American College of Gastroenterology (ACG) recommended biofeedback for defecation disorders (strong recommendation; moderate-quality evidence), levator syndrome (strong recommendation; very low-quality evidence), and fecal incontinence (strong recommendation; moderate-quality evidence) (Wald, 2021).
• The ACG fecal incontinence guideline stated that pelvic floor rehabilitative techniques including biofeedback are effective and superior to exercises alone (strong recommendation, moderate quality of evidence), noting contraindications including isolated internal anal sphincter weakness, overflow incontinence with behavioral/psychiatric disorders, neurological disorders with substantial loss of rectal sensation, decreased rectal storage capacity, or major structural damage (Wald, 2014).
• The American Gastroenterological Association (AGA) stated that biofeedback improves symptoms in more than 70% of patients with defecatory disorders and recommended biofeedback therapy rather than laxatives for defecatory disorders (strong recommendation, high-quality evidence) (Bharucha, 2013).
• The American Neurogastroenterology and Motility Society (ANMS) and European Society of Neurogastroenterology and Motility (ESNM) issued a position paper supporting biofeedback for dyssynergic defecation (Level I, Grade A) and fecal incontinence (Level II, Grade B), finding it possibly useful for levator ani syndrome (Level II, Grade B) and solitary rectal ulcer syndrome (Level III, Grade C), and not supporting it for childhood constipation (Level I, Grade D) (Rao, 2015).
• The American Society of Colon and Rectal Surgeons (ASCRS) stated that biofeedback is helpful for constipation and dyssynergic defecation (strong recommendation, 1B) (Paquette, 2016) and that biofeedback should be considered initial treatment for individuals with fecal incontinence and preserved voluntary sphincter contraction (strong recommendation, 1B) (Paquette, 2015).

Chronic Back Pain:

• The ACP recommended nonpharmacologic treatment including electromyography (EMG) biofeedback for chronic low back pain (strong recommendation) (Qaseem, 2017).
• The American College of Occupational and Environmental Medicine (ACOEM, 2016) recommended biofeedback for "highly select patients with chronic low back pain as part of a multi-disciplinary rehabilitation program" (Strength of evidence: recommended, insufficient evidence (I); level of confidence: low).

Cancer Pain:

• The NCCN (Version 1.2026) recommended biofeedback as an optional nonpharmacologic intervention to reduce pain (2A recommendation).

Neurofeedback:

• The AAP clinical practice guideline listed electroencephalogram (EEG) biofeedback among interventions with "too little evidence to recommend them or have been found to have little or no benefit" for attention-deficit/hyperactivity disorder (ADHD) (Wolraich, 2019).

Autonomic regulation (in the context of biofeedback): The modulation of sympathetic and parasympathetic nervous system activity through behavioral techniques such as controlled breathing, relaxation, and biofeedback.

Biofeedback: A therapeutic technique in which electronic monitoring provides real-time information about physiologic processes (e.g., muscle activity, heart rate, skin conductance) that are typically not consciously perceived, with the goal of enabling voluntary control over those processes to improve symptoms or functional status.

Electroencephalography (EEG) biofeedback (also called neurofeedback): A form of biofeedback that provides real-time information about brain electrical activity (EEG signals), with the goal of training individuals to modulate patterns of brain activity associated with specific symptoms or conditions.

Electromyography (EMG) biofeedback: A biofeedback method that uses sensors to measure muscle electrical activity and provides feedback to help individuals modify muscle tension and improve neuromuscular control.

Galvanic skin response (GSR) biofeedback (also called electrodermal activity): A biofeedback method that measures changes in skin conductance associated with sympathetic nervous system activity, used to help individuals regulate stress and emotional arousal.

Heart rate variability (HRV) biofeedback: A biofeedback method that provides information about variations in time intervals between heartbeats, with the goal of improving autonomic regulation through controlled breathing and relaxation techniques.

Minimal clinically important difference (MCID): The smallest change in an outcome measure that is perceived as meaningful by individuals or that would prompt a change in management.

Pelvic floor biofeedback: A form of EMG or pressure-based biofeedback used to provide feedback on pelvic floor muscle activity to improve coordination and strength, commonly used in urinary or fecal incontinence and defecatory disorders.

Pressure biofeedback: A method that uses pressure sensors (e.g., intravaginal or anorectal devices) to provide feedback on muscle contraction or relaxation, often used in pelvic floor rehabilitation.

Respiratory biofeedback: A technique that provides feedback on breathing rate and pattern to promote slow, controlled respiration, often used in conjunction with HRV biofeedback.

Sham biofeedback: A control condition in which individuals receive feedback not contingent on their own physiologic signals, used in research to control for placebo and nonspecific effects.

Thermal biofeedback: A biofeedback method that measures peripheral skin temperature as an indirect indicator of blood flow, used to help individuals influence vasodilation and stress-related physiologic responses.

Peer Reviewed Publications:

1. Ba-Bai-Ke-Re MM, Wen NR, Hu YL, et al. Biofeedback-guided pelvic floor exercise therapy for obstructive defecation: an effective alternative. World J Gastroenterol. 2014; 20(27):9162-9169.
2. Babu AS, Mathew E, Danda D, Prakash H. Management of patients with fibromyalgia using biofeedback: a randomized control trial. Indian J Med Sci. 2007; 61(8):455-461.
3. Barber MD, Spino C, Janz NK, et al. The minimum important differences for the urinary scales of the Pelvic Floor Distress Inventory and Pelvic Floor Impact Questionnaire. Am J Obstet Gynecol. 2009; 200(5):580.e1-580.e7.
4. Barnes KL, Cichowski S, Komesu YM, et al. Home biofeedback versus physical therapy for stress urinary incontinence: a randomized trial. Female Pelvic Med Reconstr Surg. 2021; 27(10):587-594.
5. Breteler MH, Arns M, Peters S, et al. Improvements in spelling after QEEG-based neurofeedback in dyslexia: a randomized controlled treatment study. Appl Psychophysiol Biofeedback. 2010; 35(1):5-11.
6. Burgio KL, Goode PS, Locher JL, et al. Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial. JAMA. 2002; 288(18):2293-2299.
7. Burgio KL, Goode PS, Urban DA, et al. Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: a randomized, controlled trial. J Urol. 2006; 175(1):196-201.
8. Climov D, Lysy C, Berteau S, et al. Biofeedback on heart rate variability in cardiac rehabilitation: practical feasibility and psycho-physiological effects. Acta Cardiol. 2014; 69(3):299-307.
9. Deng X, Wang G, Zhou L, et al. Randomized controlled trial of adjunctive EEG-biofeedback treatment of obsessive-compulsive disorder. Shanghai Arch Psychiatry. 2014; 26(5):272-279.
10. de Oliveira AKA, da Costa KSA, de Lucena GL, et al. Comparing exercises with and without electromyographic biofeedback in subacromial pain syndrome: a randomized controlled trial. Clin Biomech (Bristol, Avon). 2022; 93:105596.
11. Dost Sürücü G, Tezen Ö. The effect of EMG biofeedback on lower extremity functions in hemiplegic patients. Acta Neurol Belg. 2021; 121(1):113-118.
12. Elbogen EB, Alsobrooks A, Battles S, et al. Mobile neurofeedback for pain management in veterans with TBI and PTSD. Pain Med. 2021; 22(2):329-337.
13. Fitz FF, Resende AP, Stupp L, et al. Biofeedback for the treatment of female pelvic floor muscle dysfunction: a systematic review and meta-analysis. Int Urogynecol J. 2012; 23(11):1495-1516.
14. Fruchter E, Goldenthal N, Adler LA, et al. Amygdala-derived-EEG-fMRI-pattern neurofeedback for the treatment of chronic post-traumatic stress disorder. A prospective, multicenter, multinational study evaluating clinical efficacy. Psychiatry Res. 2024; 333:115711.
15. Gabrielsen KB, Clausen T, Haugland SH, et al. Infralow neurofeedback in the treatment of substance use disorders: a randomized controlled trial. J Psychiatry Neurosci. 2022; 47(3):E222-E229.
16. Geng HZ, Xu C, Cong J, Li Y. Magnetoelectric biofeedback for precision-targeted rectocele management: a randomized controlled trial of phenotype-driven pelvic floor neuromodulation. Int J Colorectal Dis. 2026; 41:76.
17. Gerchen MF, Kirsh M, Bahs N, et al. The SyBil-AA real-time fMRI neurofeedback study: protocol of a single-blind randomized controlled trial in alcohol use disorder. BMC Psychiatry. 2018; 18(1):12.
18. Greenhalgh J, Dickson R, Dundar Y. The effects of biofeedback for the treatment of essential hypertension: a systematic review. Health Technol Assess. 2009; 13(46):1-104.
19. Guo Y, Gao F, Li J, et al. Effect of electromyographic biofeedback training on motor function of quadriceps femoris in patients with incomplete spinal cord injury: a randomized controlled trial. NeuroRehabilitation. 2021; 48(3):345-351.
20. Hagen S, Bugge C, Dean SG, et al. Basic versus biofeedback-mediated intensive pelvic floor muscle training for women with urinary incontinence: the OPAL RCT. Health Technol Assess. 2020a; 24(70):1-144.
21. Hagen S, Elders A, Stratton S, et al. Effectiveness of pelvic floor muscle training with and without electromyographic biofeedback for urinary incontinence in women: multicentre randomised controlled trial. BMJ. 2020b; 371:m3719.
22. Hall E, Keyser L, McKinney J, et al. Real-world evidence from a digital health treatment program for female urinary incontinence: observational study of outcomes following user-centered product design. JMIR Form Res. 2024; 8:e58551.
23. Hancock M, Smith A, O'Sullivan P, et al. Cognitive functional therapy with or without movement sensor biofeedback versus usual care for chronic, disabling low back pain (RESTORE): 3-year follow-up of a randomised, controlled trial. Lancet Rheumatol. 2025; 7(11):e789-e798.
24. Hasslinger J, Jonsson U, Bölte S. Immediate and sustained effects of neurofeedback and working memory training on cognitive functions in children and adolescents with ADHD: a multi-arm pragmatic randomized controlled trial. J Atten Disord. 2022; 26(11):1492-1506.
25. Herhaus B, Siepmann M, Kahaly GJ, et al. Effect of a biofeedback intervention on heart rate variability in individuals with panic disorder: a randomized controlled trial. Psychosom Med. 2022; 84(2):199-209.
26. Hetkamp M, Bender J, Rheindorf N, et al. A systematic review of the effect of neurofeedback in cancer patients. Integr Cancer Ther. 2019; 18(1):1-13.
27. Hsu LF, Liao YM, Lai FC, Tsai PS. Beneficial effects of biofeedback-assisted pelvic floor muscle training in patients with urinary incontinence after radical prostatectomy: a systematic review and metaanalysis. Int J Nurs Stud. 2016; 60:99-111.
28. Keyser LE, McKinney JL, Pulliam SJ, Weinstein MM. A digital health program for treatment of urinary incontinence: retrospective review of real-world user data. Int Urogynecol J. 2023; 34(5):1083-1089.
29. Klijn AJ, Uiterwaal CS, Vijverberg MA, et al. Home uroflowmetry biofeedback in behavioral training for dysfunctional voiding in school-age children: a randomized controlled study. J Urol. 2006; 175(6):2263-2268.
30. Koldenhoven RK, Jaffri AH, DeJong AF, et al. Gait biofeedback and impairment-based rehabilitation for chronic ankle instability. Scand J Med Sci Sports. 2021; 31(1):193-204.
31. Kouijzer ME, van Schie HT, Gerritis BJ, et al. Is EEG-biofeedback an effective treatment in autism spectrum disorders? A randomized controlled trial. Appl Psychophysiol Biofeedback. 2013; 38(1):17-28.
32. Lam SL, Criaud M, Lukito S, et al. Double-blind, sham-controlled randomized trial testing the efficacy of fMRI neurofeedback on clinical and cognitive measures in children with ADHD. Am J Psychiatry. 2022; 179(12):947-958.
33. Lirio-Romero C, Torres-Lacomba M, Gómez-Blanco A, et al. Electromyographic biofeedback improves upper extremity function: a randomized, single-blinded, controlled trial. Physiotherapy. 2021; 110:54-62.
34. Liu M, Xu L, Li H, et al. Morphological and functional changes of the tibialis anterior muscle after combined mirror visual feedback and electromyographic biofeedback in poststroke patients: a randomized trial. Am J Phys Med Rehabil. 2021; 100(8):766-773.
35. Malenfant D, Catton M, Pope JE. The efficacy of complementary and alternative medicine in the treatment of Raynaud's phenomenon: a literature review and meta-analysis. Rheumatology (Oxford). 2009; 48(7):791-795.
36. Maynart WHDC, Albuquerque MCDS, Santos RCS, et al. The use of biofeedback intervention in the improvement of depression levels: a randomised trial. Acta Neuropsychiatr. 2021; 33(3):126-133.
37. Mennella R, Patron E, Palomba D. Frontal alpha asymmetry neurofeedback for the reduction of negative affect and anxiety. Behav Res Ther. 2017; 92:32-40.
38. Micoulaud-Franchi JA, Geoffroy PA, Fond G, et al. EEG neurofeedback treatments in children with ADHD: an updated meta-analysis of randomized controlled trials. Front Hum Neurosci. 2014; 8:906.
39. Mihara M, Fujimoto H, Hattori N, et al. Effect of neurofeedback facilitation on poststroke gait and balance recovery: a randomized controlled trial. Neurology. 2021; 96(21):e2587-e2598.
40. Moore D, Young CJ. A systematic review and meta-analysis of biofeedback therapy for dyssynergic defaecation in adults. Tech Coloproctol. 2020; 24(9):909-918.
41. Nagai Y, Aram J, Koepp M, et al. Epileptic seizures are reduced by autonomic biofeedback therapy through enhancement of fronto-limbic connectivity: a controlled trial and neuroimaging study. EBioMedicine. 2018; 27:112-122.
42. Nestoriuc Y, Martin A. Efficacy of biofeedback for migraine: a meta-analysis. Pain. 2007; 128(1-2):111-127.
43. Nestoriuc Y, Rief W, Martin A. Meta-analysis of biofeedback for tension-type headache: efficacy, specificity, and treatment moderators. J Consult Clin Psychol. 2008; 76(3):379-396.
44. Neurofeedback Collaborative Group. Double-blind placebo-controlled randomized clinical trial of neurofeedback for attention-deficit/hyperactivity disorder with 13 month follow-up. J Am Acad Child Adolesc Psychiatry. 2021; 60(7):841-855.
45. Nolan RP, Floras JS, Harvey PJ, et al. Behavioral neurocardiac training in hypertension: a randomized, controlled trial. Hypertension. 2010; 55(4):1033-1039.
46. Nunes EFC, Sampaio LMM, Biasotto-Gonzalez DA, et al. Biofeedback for pelvic floor muscle training in women with stress urinary incontinence: a systematic review with meta-analysis. Physiotherapy. 2019; 105(1):10-23.
47. Olsson EM, El Alaoui S, Carlberg B, et al. Internet-based biofeedback-assisted relaxation training in the treatment of hypertension: a pilot study. Appl Psychophysiol Biofeedback. 2010; 35(2):163-170.
48. Palermo TM, Eccleston C, Lewandowski AS, et al. Randomized controlled trials of psychological therapies for management of chronic pain in children and adolescents: an updated meta-analytic review. Pain. 2010; 148(3):387-397.
49. Panisch LS, Hai AH. The effectiveness of using neurofeedback in the treatment of post-traumatic stress disorder: a systematic review. Trauma Violence Abuse. 2020; 21(3):541-550.
50. Patel UJ, Keyser LE, Gontarczyk Uczkowski N, et al. Home-based biofeedback for fecal incontinence: a randomized clinical trial. Urogynecology. 2026; 32(4):464-473.
51. Renton T, Tibbles A, Topolovec-Vranic J. Neurofeedback as a form of cognitive rehabilitation therapy following stroke: a systematic review. PLoS One. 2017; 12(5):e0177290.
52. Roy R, de la Vega R, Jensen MP, et al. Neurofeedback for pain management: a systematic review. Front Neurosci. 2020; 14:671.
53. Roy S, Mandal N, Ray A, et al. Effectiveness of neurofeedback training, behaviour management including attention enhancement training and medication in children with attention-deficit/hyperactivity disorder - a comparative follow up study. Asian J Psychiatr. 2022; 76:103133.
54. Sahin N, Yesil H, Gorcan B. The effect of pelvic floor exercises performed with EMG biofeedback or a vaginal cone on incontinence severity, pelvic floor muscle strength, and quality of life in women with stress urinary incontinence: a randomized, 6-month follow-up study. Int Urogynecol J. 2022; 33(10):2773-2779.
55. Sam E, Cinislioglu AE, Yilmazel FK, et al. Is biofeedback-assisted pelvic floor muscle training superior to pelvic floor muscle training alone in the treatment of dysfunctional voiding in women? A prospective randomized study. Int Braz J Urol. 2022; 48(3):501-511.
56. Schabus M, Griessenberger H, Gnjezda MT, et al. Better than sham? A double-blind placebo-controlled neurofeedback study in primary insomnia. Brain. 2017; 140(4):1041-1052.
57. Scharff L, Marcus DA, Masek BJ. A controlled study of minimal-contact thermal biofeedback treatment in children with migraine. J Pediatr Psychol. 2002; 27(2):109-119.
58. Scott WC, Kaiser D, Othmer S, et al. Effects of an EEG biofeedback protocol on a mixed substance abusing population. Am J Drug Alcohol Abuse. 2005; 31(3):455-469.
59. Shahrbanian S, Hashemi A, Hemayattalab R. The comparison of the effects of physical activity and neurofeedback training on postural stability and risk of fall in elderly women: a single-blind randomized controlled trial. Physiother Theory Pract. 2021; 37(2):271-278.
60. Sielski R, Rief W, Glombiewski JA. Efficacy of biofeedback in chronic back pain: a meta-analysis. Int J Behav Med. 2017; 24(1):25-41.
61. Simón MA, Bueno AM, Otero P, et al. A randomized controlled trial on the effects of electromyographic biofeedback on quality of life and bowel symptoms in elderly women with dyssynergic defecation. Int J Environ Res Public Health. 2019; 16(18):3524.
62. Sokhadze TM, Cannon RL, Trudeau DL. EEG biofeedback as a treatment for substance use disorders: review, rating of efficacy, and recommendations for further research. Appl Psychophysiol Biofeedback. 2008; 33(1):1-28.
63. Steingrimsson S, Bilonic G, Ekelund AC, et al. Electroencephalography-based neurofeedback as treatment for post-traumatic stress disorder: a systematic review and meta-analysis. Eur Psychiatry. 2020; 63(1):e7.
64. Strehl U, Birkle SM, Worz S, Kotchoubey B. Sustained reduction of seizures in patients with intractable epilepsy after self-regulation training of slow cortical potentials - 10 years after. Front Hum Neurosci. 2014; 8:604.
65. Stubberud A, Varkey E, McCrory DC, et al. Biofeedback as prophylaxis for pediatric migraine: a meta-analysis. Pediatrics. 2016; 138(2):e20160675.
66. Tiryaki P, Çelik D, Bilsel K, Erşen A. Effectiveness of exercises with electromyographic biofeedback in conservative treatment of massive rotator cuff tears: a randomized controlled study. Am J Phys Med Rehabil. 2023; 102(5):419-426.
67. Trautmann E, Lackschewitz H, Kröner-Herwig B. Psychological treatment of recurrent headache in children and adolescents-a meta-analysis. Cephalalgia. 2006; 26(12):1411-1426.
68. Van der Kolk BA, Hodgdon H, Gapen M, et al. A randomized controlled study of neurofeedback for chronic PTSD. PLoS One. 2016; 11(12):e0166752.
69. Van Doren J, Arns M, Heinrich H, et al. Sustained effects of neurofeedback in ADHD: a systematic review and meta-analysis. Eur Child Adolesc Psychiatry. 2019; 28(3):293-305.
70. Vasudeva S, Claggett AL, Tietjen GE, McGrady AV. Biofeedback-assisted relaxation in migraine headache: relationship to cerebral blood flow velocity in the middle cerebral artery. Headache. 2003; 43(3):245-250.
71. Weinstein MM, Dunivan G, Guaderrama NM, Richter HE. Digital therapeutic device for urinary incontinence: a randomized controlled trial. Obstet Gynecol. 2022; 139(4):606-615.
72. Weinstein MM, Dunivan GC, Guaderrama NM, Richter HE. Digital therapeutic device for urinary incontinence: a longitudinal analysis at 6 and 12 months. Obstet Gynecol. 2023; 141(1):199-206.
73. Weinstein MM, Dunivan GC, Guaderrama NM, Richter HE. A motion-based device urinary incontinence treatment: a longitudinal analysis at 18 and 24 months. Int Urogynecol J. 2024; 35(4):803-810.
74. Weinstein MM, Dunivan GC, Guaderrama NM, Richter HE. Impact of a digital therapeutic device on pelvic floor symptoms. Urogynecology. 2025; 31(5):528-534.
75. Weise C, Heinecke K, Rief W. Biofeedback-based behavioral treatment for chronic tinnitus: results of a randomized controlled trial. J Consult Clin Psychol. 2008; 76(6):1046-1057.
76. Wolraich ML, Hagan JF Jr, Allan C. Subcommittee on children and adolescents with attention deficit/hyperactive disorder. Clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics. 2019; 144(4):e20192528.
77. Wu X, Zheng X, Yi X, et al. Electromyographic biofeedback for stress urinary incontinence or pelvic floor dysfunction in women: a systematic review and meta-analysis. Adv Ther. 2021; 38(8):4163-4177.
78. Yan L, Wang S, Yuan Y, et al. Effects of neurofeedback versus methylphenidate for the treatment of ADHD: systematic review and meta-analysis of head-to-head trials. Evid Based Ment Health. 2019; 22(3):111-117.
79. Yakşi E, Yaşar MF, Türel CA, Balcı M. Are static posturography-assisted biofeedback exercises effective in Parkinson's disease? Arq Neuropsiquiatr. 2022; 80(9):935-943.
80. Young KD, Siegle GJ, Zotev V, et al. Randomized clinical trial of real-time FMRI amygdala neurofeedback for major depressive disorder: effects on symptoms and autobiographical memory recall. Am J Psychiatry. 2017; 174(8):748-755.

Government Agency, Medical Society, and Other Authoritative Publications:

1. Ailani J, Burch RC, Robbins MS; Board of Directors of the American Headache Society. The American Headache Society consensus statement: update on integrating new migraine treatments into clinical practice. Headache. 2021; 61(7):1021-1039.
2. American College of Occupational and Environmental Medicine (ACOEM). Low back disorders. 2016. Available at: https://www.dir.ca.gov/dwc/MTUS/ACOEM-Guidelines/Low-Back-Disorders-Guideline.pdf. Accessed on June 9, 2026.
3. American College of Obstetricians and Gynecologists (ACOG). ACOG practice bulletin no. 155: urinary incontinence in women. Obstet Gynecol. 2015; 126(5):e66-e81.
4. Bharucha AE, Dorn SD, Lembo A, Pressman A. American Gastroenterological Association medical position statement on constipation. Gastroenterology. 2013; 144(1):211-217.
5. Breyer BN, Sandhu JS, Comiter C, et al. Incontinence after prostate treatment: AUA/GURS/SUFU guideline (2019; amended 2024). American Urological Association; 2024.
6. Cameron AP, Chung DE, Dielubanza EJ, et al. The AUA/SUFU guideline on the diagnosis and treatment of idiopathic overactive bladder. J Urol. 2024; 212(1):11-20.
7. Fernandes ACNL, Jorge CH, Weatherall M, et al. Pelvic floor muscle training with feedback or biofeedback for urinary incontinence in women. Cochrane Database Syst Rev. 2025;(3):CD009252.
8. Johnson EE, Mamoulakis C, Stoniute A, et al. Conservative interventions for managing urinary incontinence after prostate surgery. Cochrane Database Syst Rev. 2023; 4(4):CD014799.
9. Kobashi KC, Vasavada S, Bloschichak A, et al. Updates to surgical treatment of female stress urinary incontinence (SUI): AUA/SUFU guideline (2023). J Urol. 2023; 209(6):1091-1098.
10. NCCN Clinical Practice Guidelines in Oncology®. ©2026 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: https://www.nccn.org. Accessed on March 26, 2026.
    • Adult Cancer Pain (Version 1.2026). Revised January 23, 2026.
11. Paquette IM, Varma MG, Kaiser AM, et al. The American Society of Colon and Rectal Surgeons' clinical practice guideline for the treatment of fecal incontinence. Dis Colon Rectum. 2015; 58(7):623-636.
12. Paquette IM, Varma M, Tement C, et al. The American Society of Colon and Rectal Surgeons' clinical practice guideline for the evaluation and management of constipation. Dis Colon Rectum. 2016; 59(6):479-492.
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15. Rao SSC, Benninga MA, Bharucha AE, et al. ANMS-ESNM position paper and consensus guidelines on biofeedback therapy for anorectal disorders. Neurogastroenterol Motil. 2015; 27(5):594-609.
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17. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. Rockville, MD: FDA. LEVA Pelvic Health System (Renovia, Inc.). No. K212495. Available at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=k212495. Accessed on  June 9, 2026.
18. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health 510(k) Premarket Notification Database. Summary of Safety and Effectiveness. Rockville, MD: FDA. Prism (Gray Matters Health Ltd.). No. K222101. Available at: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222101.pdf. Accessed on June 9, 2026.
19. Wald A, Bharucha AE, Cosman BC, Whitehead WE. ACG clinical guideline: management of benign anorectal disorders. Am J Gastroenterol. 2014; 109(8):1141-1157.
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21. Woodward S, Norton C, Chiarelli P. Biofeedback for treatment of chronic idiopathic constipation in adults. Cochrane Database Syst Rev. 2014; (3):CD008486.

Biofeedback
EEG Biofeedback (Neurofeedback)
Leva Pelvic Health System
Neurofeedback
Prism

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