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 EEG biofeedback) is a type of biofeedback that uses electroencephalograms (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 EMG (sEMG) such as the SPEAC sEMG activity alert system:

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

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. autistic 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.

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:

Biofeedback

Biofeedback is a training program in which an individual is given information about physiological processes through electronic monitoring, with the goal of gaining conscious control and influencing those processes. Examples of such physiologic processes include heart rate, blood pressure, and muscle tension. The theory of biofeedback is that these processes reflect the activity of a clinical disorder and, by controlling those physiologic processes, 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 variability, and galvanic skin response.

Biofeedback for Migraine and Tension Headaches

Randomized controlled trials (RCTs) and systematic reviews of studies on adults and children with migraine or tension headaches have shown that biofeedback is associated with a decrease in headache pain and less use of migraine medication compared with self-relaxation therapy alone (Nestoriuc and Martin, 2007; Nestoriuc, 2008; Palermo, 2010; Scharff, 2002; Stubberud, 2016; Trautmann, 2006; Vasudeva, 2003).

The American Academy of Neurology (AAN) (Silberstein, 2009) recommendations for the evaluation and treatment of migraine headaches stated that relaxation training, thermal biofeedback combined with relaxation training, electromyographic biofeedback, and cognitive-behavioral therapy may be considered treatment options for prevention of migraine. Although these modalities may be effective as monotherapy, they are more commonly used in conjunction with pharmacologic management.

The National Institute of Neurologic Disorders and Stroke (NINDS, 2018) stated “drug therapy, biofeedback training, stress reduction, and elimination of certain foods from the diet are the most common methods of preventing and controlling migraine and other vascular headaches. Drug therapy for migraine is often combined with biofeedback and relaxation training.”

Biofeedback for Urinary Incontinence

Biofeedback for 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 facilitate training to 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; Herderschee, 2011; Hsu, 2016; Johnson, 2023; Moroni, 2016; Nunes 2019). Conclusions of individual RCTs were mixed. For example, Hagen (2020a and 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.

In 2011, Herderschee and colleagues published a Cochrane review on biofeedback added to PFMT for urinary incontinence in women. The authors reviewed 24 trials (n=1583), 17 of which examined the primary outcome of interest. The authors found that women who received biofeedback reported better outcomes than those who received muscle training alone (risk ratio [RR] 0.75; 95% confidence interval [CI], 0.66 to 0.86). They noted that additional trials were needed to determine whether biofeedback, or general feedback from a healthcare practitioner, was responsible for the superior outcomes.

Moroni and colleagues (2016) performed a systematic review and meta-analysis of RCTs to assess conservative management of stress urinary incontinence for adult women. The authors included trials that compared PFMT without biofeedback to no treatment (n=122), and to PFMT plus biofeedback (n=250). The authors concluded that, although biofeedback during PFMT exercises did not lead to systematically better results than PFMT alone, biofeedback may be an option in women who cannot adequately isolate and contract their pelvic floor muscles.

In a guideline on the nonsurgical management of urinary incontinence in women (Qaseem, 2014), the American College of Physicians (ACP) states that “pelvic floor muscle training alone and in combination with bladder training or biofeedback and weight loss with exercise for obese women were effective at achieving continence and improving UI [urinary incontinence].”

The American Urological Society (AUA) published a guideline (Kobashi, 2023) stating that pelvic floor muscle training, with or without biofeedback, should be offered to individuals with stress urinary incontinence or stress-predominant mixed urinary incontinence.

In a clinical guideline addressing urinary incontinence in women (ACOG 2015; reaffirmed 2018), the American College of Obstetricians and Gynecologists (ACOG) states that “pelvic muscle exercises may be used alone or augmented with bladder training, biofeedback, or electrical stimulation. Pelvic floor muscle exercises can be effective as a first-line treatment for stress, urgency, or mixed urinary incontinence.”

In 2021, Wu and colleagues published a systematic review and meta-analysis evaluating the effectiveness of combining electromyographic biofeedback (EMG-BF) with PFMT compared to PFMT alone for managing stress urinary incontinence and pelvic floor dysfunction. 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 (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 1.72, p<0.001) and improved quality of life and sexual function scores. Study limitations included high heterogeneity among studies and an over representation of studies conducted in China, highlighting the need for further randomized controlled trials in diverse populations.

In 2024, Cameron and colleagues published guidelines by the AUA on the Diagnosis and Treatment of Idiopathic Overactive Bladder which strongly recommends that clinicians offer bladder training for all individuals with overactive bladder disorder but that biofeedback may not confer additional benefit as an adjunct to PFMT when overactive bladder is the primary contributing factor to incontinence.

Biofeedback for Chronic Constipation, Fecal Incontinence, and Anorectal Disorders

Several guidelines and systematic reviews of RCTs addressing chronic constipation and fecal incontinence have been published.

In 2020, Moore and colleagues evaluated RCTs comparing any type of biofeedback to a different intervention in individuals who met the Rome criteria for dyssynergic defecation. A total of 11 trials with 725 participants met the inclusion criteria. The authors identified a large amount of heterogeneity among trials. In a pooled analysis of 6 RCTs, biofeedback had a significantly greater benefit on global clinical improvement, the primary outcome, compared with control interventions (OR, 3.63; 95% CI, 1.10 to 11.93; p=0.03).

Woodward and colleagues (2014) published a systematic review examining the effectiveness of biofeedback therapy for the treatment of chronic constipation in adults. The researchers included 17 RCTs (total n=931) that compared different biofeedback methods, compared biofeedback to sham treatment, or compared biofeedback to standard treatment. They found that supervised computer-assisted biofeedback was superior to sedatives, shams, laxatives, and lifestyle changes (diet and exercise). Some surgeries were found superior but had more side effects, whereas biofeedback was not found to cause any side effects or 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).

In a practice guideline (Wald 2021), the American College of Gastroenterology (ACG) made the following recommendations:

• We recommend that instrumented anorectal biofeedback therapy should be used to manage symptoms in defecation disorders (DD) (strong recommendation; minimal risk of harm; quality of evidence: moderate). Consensus score: 29.
• We recommend biofeedback to teach pelvic floor muscle reconditioning for levator syndrome with abnormal ARM (strong recommendation; quality of evidence: very low). Consensus score: 26.
• We recommend that patients with FI [fecal incontinence] who do not respond to education and conservative measures should undergo biofeedback (i.e., pelvic floor rehabilitative techniques with visual or auditory feedback) (strong recommendation; quality of evidence: moderate). Consensus score: 30.

The ACG guideline addressing fecal incontinence (Wald, 2014) stated “pelvic floor rehabilitative techniques [including manometric or EMG-assisted biofeedback therapy] are effective and superior to pelvic floor exercises alone in patients with FI [fecal incontinence] who do not respond to conservative measures (strong recommendation, moderate quality of evidence).” However, ACG noted:

Biofeedback is not indicated in patients with isolated internal anal sphincter weakness, overflow incontinence associated with behavioral or psychiatric disorders, neurological disorders associated with substantial loss of rectal sensation and/or the inability to contract the striated muscles, decreased rectal storage capacity from resection, inflammation or fibrosis, or major structural damage to continence mechanisms.

The American Gastroenterological Association (AGA) published a medical position on constipation (Bharucha, 2013) that stated the following:

Biofeedback therapy improves symptoms in more than 70% of patients with defecatory disorders. The motivation of the patient and therapist, the frequency and intensity of the retraining program, and the involvement of behavioral psychologists and dietitians as necessary all likely contribute to the chances of success…Pelvic floor retraining by biofeedback therapy rather than laxatives is recommended for defecatory disorders (strong recommendation, high-quality evidence).

The American Neurogastroenterology and Motility Society (ANMS) and the European Society of Neurogastroenterology and Motility (ESNM) published guidelines (Rao, 2015) on the efficacy of biofeedback that concluded the following:

Based on the strength of evidence, biofeedback therapy is recommended for the short term and long term treatment of constipation with dyssynergic defecation (Level I, Grade A), and for the treatment of fecal incontinence (Level II, Grade B). Biofeedback therapy may be useful in the short-term treatment of Levator Ani Syndrome with dyssynergic defecation (Level II, Grade B), and solitary rectal ulcer syndrome with dyssynergic defecation (Level III, Grade C), but the evidence is fair. Evidence does not support the use of biofeedback for the treatment of childhood constipation (Level 1, Grade D)…Treatment recommendations were based on grading recommended by the U.S. Preventive Services Task Force [https://‌www.‌uspreventive‌servicestaskforce‌.org].

In a clinical practice guideline for the evaluation and management of constipation (Paquette, 2016), the American Society of Colon and Rectal Surgeons (ASCRS) stated that biofeedback is helpful for constipation and dyssynergic defecation (strong recommendation based on moderate-quality evidence, 1B). Their guideline on treatment of fecal incontinence (Paquette, 2015) stated “biofeedback should be considered as an initial treatment for patients with incontinence and some preserved voluntary sphincter contraction. Grade of Recommendation: Strong recommendation based on moderate-quality evidence, 1B.”

Biofeedback for Chronic Back Pain

In a meta-analysis on the efficacy of biofeedback for chronic back pain, Sielski and colleagues (2017) evaluated 21 studies (n=1062). They found 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 follow-up. The researchers also found improvement in depression, disability, muscle tension, and coping.

In a clinical practice guideline on treatments for back pain (Qaseem, 2017), the ACP recommended that clinicians initially prescribe nonpharmacologic treatment for chronic low back pain, including electromyography biofeedback (Grade: strong recommendation).

The American College of Occupational and Environmental Medicine (ACOEM) 2016 guidelines on low back disorders 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).

Biofeedback for Cancer Pain

In their guideline on adult cancer pain (V.1.2025), the National Comprehensive Cancer Network (NCCN) recommended biofeedback as an optional component of an integrative intervention to reduce pain (2A recommendation).

Biofeedback for 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’s disease (Yakşi, 2022), Raynaud’s syndrome (Malenfant, 2009), rotator cuff tear (Tiryaki , 2023), subacromial pain syndrome (de Oliveira, 2022) and tinnitus (Weise, 2008).

Home use of Biofeedback Devices

In 2022, Keyser published results of a retrospective cohort study of real-world data from users of pelvic floor muscle training using a digital, motion-based, intravaginal wand-like device (LEVA® Pelvic Health System; Renovia, Inc., Boston, MA) The primary outcome was the change in Urogenital Distress Inventory, Short Form (UDI-6) score. Enrolled participants were at least 18 years of age with a diagnosis of stress incontinence, urgency, or mixed urinary incontinence (n=265).  At the end of the 8-week study period, the mean improvement in UDI-6 score was 13.90 (p≤0.001); 62% of study participants achieved a minimal clinically important difference (MCID) in symptoms. At week 4, device-use adherence (defined as, 14 uses/week) was 72% and at 8 weeks 66%. Study in the setting of a RCT is warranted.

In 2022, Weinstein and colleagues published results of a study evaluating the effect of pelvic floor muscle training using the LEVA® Pelvic Health System compared to home pelvic floor muscle training for the treatment of stress or stress-predominant mixed urinary incontinence. The study was an 8-week, open-label, randomized controlled trial (RCT) conducted remotely, involving participants with stress or stress-predominant mixed urinary incontinence. A total of 143 participants used the device, while 156 performed the exercises at home. Participants were at least 18 years old and had experienced urinary incontinence for at least 3 months. The study's primary outcome was the change in the Urogenital Distress Inventory (UDI-6) score and the number of stress urinary incontinence episodes over three days, as reported in a bladder diary, both assessed eight weeks after starting treatment. The results showed that the device group had a greater average improvement in UDI-6 scores (18.8 compared to 14.7 in the control group, p=0.01). The median number of urinary incontinence episodes decreased from 5 to 1 in the device group, and to 2 in the control group (p=0.005). More participants in the device group reported feeling "much improved" or "very much improved" compared to the control group (OR, 1.94; 95% confidence interval [CI], 1.21-3.15). There were no serious adverse effects related to the device, but vaginal irritation was reported by one participant (0.55%) in the control group and five participants (2.7%) in the device group. Despite these statistical findings, the difference of 4 points between groups in the UDI-6 score was less than the minimum clinically important difference (MCID) of 11 points. Additionally, although the reduction in urinary incontinence episodes was statistically significant, there was a 75% overlap in outcomes, making the real-world significance uncertain. The device group had a 69% adherence rate by device report (84% by self-report), while the control group reported 89% adherence to exercises. Secondary symptom scales showed significant improvement in both groups without notable differences between them. Although some short-term benefits were observed, the use of a digital intravaginal device did not show superior clinical effectiveness compared to home exercises for urinary incontinence and resulted in more cases of vaginal irritation.

In 2023, Weinstein and colleagues published results of the long-term efficacy of the LEVA Pelvic Health System from the RCT described above. In this planned secondary analysis, symptom and adherence data were collected at 6- and 12-months following baseline. From the 299 participants available for analysis in the initial 8-week study, 286 (95.7%) returned for this planned follow-up analysis (n=151 in the control arm and n=135 in the intervention arm). The mean change in UDI-6 score from at 6 and 12 months was marginally, but significantly greater in the intervention arm compared to the control arm (20.2 vs. 14.8, p=0.03 and 22.7 vs. 15.9, p=0.01, respectively). This difference between groups still did not reach the MCID for changes in the UDI-6 score. While participants in the intervention group had more than twice the odds of reporting improvement on the Patient Global Impression of Improvement compared with the control group (OR, 2.45, 95% CI: 1.49-4.00), five additional related self-report measures (Pelvic Floor Impact Questionnaire, Incontinence Impact Questionnaire, Pelvic Organ Prolapse Distress Inventory 6; Colorectal Anal Distress Inventory-8; and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised) were not statistically different between the groups. For the intervention group, device-reported adherence was 69% at 8 weeks, this fell to 13% at 6 months, and was 17% at 12 months. Neither arm was instructed to continue intervention past 8 weeks, as such, adherence to the pelvic floor muscle training was not captured in this extended follow-up.

The 24-month results from the original 8-week RCT was published by Weinstein in 2024. In this planned secondary analysis, a total of 231 participants were available for 24-month follow-up (23% loss to follow-up). Reported improvement according to self-reported scores from the Patient Global Impression of Improvement questionnaire were greater in the intervention group than in the control group at 24 months (35% vs. 22%, p=0.03;, OR, 1.95, [95% CI: 1.08, 3.57]). As was described in the original study, the control arm received instruction on pelvic floor exercises, but neither group was instructed to continue their interventions beyond 8 weeks.

In 2021, Barnes and colleagues conducted a randomized controlled trial comparing biofeedback without PFPT to supervised PFPT without biofeedback for treating stress urinary incontinence in 54 individuals. Biofeedback was provided using an FDA-cleared intravaginal pressure sensor. The primary outcome was quality of life improvement, measured by the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) at 3 months. Biofeedback demonstrated noninferiority to PFPT with mean ICIQ-SF score reductions of −3.95 and −4.73, respectively (p=0.009). Both treatment groups showed symptom improvements, although PFPT was more effective for overactive bladder symptoms. Notably, device usability issues were identified as barriers to home biofeedback, whereas PFPT faced challenges such as the cost of copayments and accessibility to supervised PFPT. Study limitations included a limited sample size, study participants’ non-adherence and the fact that outcomes beyond 3 months were not assessed.

Biofeedback medical devices are classified by the U.S. Food and Drug Administration (FDA) as Class II, special controls, medical devices, participant to certain limitations and exempt from 510(k) pre-market notification. Despite the availability of numerous biofeedback devices for home use, biofeedback for conditions other than urinary incontinence has not been adequately studied in home settings.

Neurofeedback (EEG Biofeedback)

Neurofeedback, the feedback of neural information, also known as EEG biofeedback, has been investigated as a treatment for a variety of conditions including ADHD, anxiety disorders, panic disorders, post-traumatic stress disorder, substance abuse disorders, and traumatic brain injury. Although related in concept to biofeedback, neurofeedback differs in that the information fed back to the individual 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 control of those waveforms can enable the individual to control the disorder.

Anxiety and Panic Disorders

Menella and colleagues (2017) published an RCT exploring the use of neurofeedback on negative affect and anxiety. The participants were 32 healthy undergraduate women who were right-handed. Asymmetrical alpha activity has been found to be influenced by handedness. Participants were randomized to receive EEG neurofeedback to increase frontal alpha symmetry (treatment group, n=16) or to increase mid-frontal alpha activity (active control group, n=16). The authors found that the intervention group had a greater increase in alpha asymmetry compared with the active control group. They also found a significant decrease in Beck Anxiety Inventory (BAI) scores pre- to post-intervention in the intervention group and no significant change in BAI scores in the active control group. This study’s results might not apply to individuals diagnosed with anxiety disorders because they were not included in the study population.

Attention-Deficit Hyperactivity Disorder (ADHD)

Several randomized controlled trials (RCTs), systematic reviews, and meta-analyses have been published on using EEG neurofeedback to treat ADHD, including works by Micoulaud-Franchi (2014), Roy (2022), Van Doren (2019), and Yan (2019).

A systematic review and meta-analysis by Van Doren and colleagues in 2019 focused on RCTs involving EEG neurofeedback for children diagnosed primarily with ADHD. To be included, studies needed to have at least 10 participants, report follow-up data between 2 to 12 months, and use DSM IV/V-based rating scales. In total, 10 studies involving 506 participants met these criteria. The meta-analysis was divided based on the control groups used: active controls (such as medication and self-management training with proven clinical benefits) and non-active controls (all other interventions). The analysis compared results from before treatment to the follow-up period. Findings showed that neurofeedback had a significant benefit over non-active controls for reducing inattention and hyperactivity/impulsivity but did not show a benefit over active controls. The effect sizes with non-active controls were small but statistically significant. Specifically:

• For inattention, the standard mean difference (SMD) was 0.38; 95% confidence interval (CI) ranged from 0.14 to 0.61.
• For hyperactivity/impulsivity, the SMD was 0.25; 95% CI ranged from 0.01 to 0.45.

In summary, EEG neurofeedback showed modest improvements in ADHD symptoms compared to non-active interventions but did not outperform active control interventions like medication or self-management training.

The systematic review by Yan and colleagues (2019) included trials published in Chinese as well as in English. They identified 18 head-to-head RCTs on neurofeedback versus methylphenidate (MPH) for treatment of ADHD (13 in Chinese, 5 in English). The studies included a total of 778 participants in the neurofeedback group and 757 in the MPH group. A meta-analysis of teacher-reported outcomes at the 6-month follow-up found that MPH was significantly more effective than neurofeedback in decreasing the severity of inattention (SMD=-0.49; 95% CI, -0.83 to -0.14) and there was no significant difference between neurofeedback and MPH on hyperactivity/impulsivity. When parent-reported outcomes were evaluated, neurofeedback was found to be significantly more effective than MPH at decreasing inattention (SMD=0.45; 95% CI, 0.04 to 0.86) and hyperactivity/impulsivity (SMD=0.69; 95% CI, 0.40 to 0.97). However, in a sensitivity analysis removing Chinese studies and studies that received no outside funding, there were no statistically significant differences between neurofeedback and MPH.

A double-blind RCT published after the systematic reviews (Neurofeedback Collaborative Group, 2020) randomized 144 children aged 7 to 10 years with moderate-to-severe ADHD to a neurofeedback intervention or a control intervention of equal duration and appearance. After 13 months, there was no statistically significant difference between groups for the primary outcome or for parent- and teacher-rated inattention. The 2020 publication noted that the study participants were to be followed for a total of 25 months. As of April, 2025, the study (NCT02251743) is listed by ClinicalTrial.gov as completed with no further publications after 2020.

In 2022, Hasslinger and colleagues evaluated the effects of neurocognitive training methods on a variety of cognitive functions in individuals (n=202) ages 9 to 17 diagnosed with ADHD. A four-arm RCT compared two types of neurofeedback to treatment as usual. Assessments were conducted at baseline, immediately after treatment, and at 6 months. The effects of Working-memory training on spatial and verbal working-memory showed some improvements over neurofeedback and treatment as usual immediately after treatment, but gains were largely lost by the 6-months follow-up. No other consistent effects were demonstrated. The authors concluded that, “The sustained effects of neurocognitive training on cognitive functioning in children and adolescents with ADHD may be limited.”

In 2022, Roy and colleagues conducted a 3-arm RCT in which they compared the efficacy of neurofeedback training, behavior management, and medication in 84 children who were 6-12 years of age and were diagnosed with ADHD. The Conners 3-P Short Scale was assessed at baseline and again at 3-month follow-up. The medication group showed the greatest reduction of core symptoms of ADHD (inattention, hyperactivity, and executive functioning). Although some improvement in core ADHD symptoms were demonstrated with all 3 intervention-types, medication conferred the most improvement.

In 2022, Lam and colleagues conducted a double-blind, sham-controlled RCT to assess the efficacy of functional MRI neurofeedback (fMRI-NF) of the inferior frontal cortex on symptoms and executive functions in 88 boys diagnosed with ADHD. Groups were assessed immediately posttreatment and at 6-month follow-up. The primary outcome was the posttreatment score on the ADHD Rating Scale (ADHD-RS). No significant group differences were found on the ADHD-RS. The authors concluded that: “the study findings do not suggest that fMRI-NF of the [right inferior frontal cortex] is effective in improving clinical symptoms or cognition in boys with ADHD.”

The American Academy of Pediatrics (AAP) clinical practice guideline on ADHD/hyperactivity disorder in children and adolescents (Wolraich, 2019) listed EEG biofeedback among the interventions that have “too little evidence to recommend them or have been found to have little or no benefit.”

Posttraumatic Stress Disorder (PTSD)

In 2020, Panisch and Hai published a systematic review of randomized and non-randomized studies on neurofeedback in the treatment of PTSD. The authors identified 10 studies, of which 3 were RCTs and 7 were pilot studies or used exploratory designs. The length of the intervention varied across studies, and range from 1 to 40 sessions. Eight studies used EEG neurofeedback and 2 used functional MRI. Eight of the 10 studies used standardized measures to assess PTSD symptoms, but a variety of measurement instruments were used. Due to differences among the studies, the authors did not pool study outcomes. The authors found that all the studies had positive findings in at least one outcome, but that there was a relatively small number of trials, with variability among study designs.

Another systematic review, published in 2020, was limited to RCTs of neurofeedback for PTSD (Steingrimsson, 2020). The authors identified four RCTs comparing EEG neurofeedback to sham treatment or to an alternative therapy in adults with PTSD. A pooled analysis was conducted for one of the primary outcomes of interest, self-reported PTSD symptoms. In a meta-analysis of three trials (total sample size=92), there was a significantly lower self-reported PTSD symptom score in the neurofeedback group compared with the comparison group (Mean difference, -2.30; 95% CI, -4.27 to -0.24). None of the studies in the pooled analysis used a sham control; one compared neurofeedback to standard care and there was a no treatment control group in the other two trials. The ability to draw conclusions from this meta-analysis is limited by the small number of trials and sample sizes, and the lack of sham interventions.

An RCT on neurofeedback for treating PTSD was published in 2016 by van der Kolk and colleagues. (This trial was included in the Steingrimsson meta-analysis, discussed above). Trial eligibility criteria included meeting DSM-IV criteria for PTSD and having had trauma-focused psychotherapy for at least 6 months. A total of 52 individuals were randomized to receive neurofeedback (n=26) or to be placed in a wait-list control group (n=26). The neurofeedback intervention consisted of 24 training sessions up to 30 minutes each occurring twice weekly; sessions were intended to train individuals to enhance alpha activity. PTSD was assessed using the Clinicians Administered PTSD scale (CAPS) which the authors stated is the gold standard measure. The CAPS can range from 0 to 136 points, with a score of at least 45 indicating a diagnosis of PTSD. A continuous CAPS measure was used as the primary efficacy endpoint. Several self-report instruments were also used to assess efficacy.

Outcomes were measured at the end of treatment and 1 month afterwards. For the primary outcome, there was significantly greater improvement in CAPS scores in the neurofeedback group compared with the waitlist group (p<0.001 for treatment by time interaction). At baseline, all participants had a CAPS score of at least 45 in the previous month. In a completer analysis 1 month after the intervention, a significantly lower proportion of individuals in the neurofeedback group (8/19, 42%) met criteria for past month PTSD than in the control group (17/19, 90%), p=0.007. Some of the self-report measures, including the Davidson Trauma Scale (DTS) and several subscales of the Inventory of Altered Self-Capacities (IASC), also significantly favored the neurofeedback group. The van der Kolk study is one of the few published RCTs on neurofeedback for treating PTSD; however it is limited by small size, a short duration of follow-up and lack of a placebo control group. Additional, adequately powered, controlled studies with longer follow-up are needed to confirm its findings and the efficacy of a particular treatment protocol.

In 2024, Fruchter and colleagues published results from an investigation of the effectiveness of Amygdala-Derived-EFP neurofeedback for treating chronic PTSD in a single-arm clinical trial. The study included 63 completing participants diagnosed with treatment-refractory PTSD, all of whom had originally been diagnosed at least 10 years earlier. Over the 8-week duration of the study, significant reductions were observed in CAPS-5 scores, which decreased by an average of 13.2 points (MCID, 6 points). Improvements in PTSD Checklist for DSM-5 (PCL-5) scores were also reported, with an average decrease of 12.7 points (MCID, 9-12 points [Blanchard, 2023]). At the 3-month follow-up, the remission rate was 31.8%, with 84% of participants showing improvement according to results on the Clinical Global Impression (CGI) measurement tool. Notable differences in response rates were reported between U.S. and non-U.S. participants at 3 months, possibly due to different trauma types. Other secondary measures, such as the Emotion Regulation Questionnaire (ERQ) and the Patient Health Questionnaire (PHQ) did not demonstrate significant improvement from baseline. Authors indicate that future, randomized trials are planned to include sham controls to validate these study findings. Additional data from adequately powered, randomized trials with well-matched controls and longer follow-up are needed to confirm the results of this, industry-sponsored, short term, single-arm study.

Neurofeedback for Other 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 treatments 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 abuse-related disorders (Gabrielsen, 2022; Gerchen, 2018; Scott, 2005; Sokhadze, 2008).

Biofeedback: The use of sensory input, such as visual or auditory signals, to make unconscious or involuntary body processes perceptible. Conscious control of the processes is intended to diminish adverse signs and symptoms of a medical condition.

Electroencephalography (EEG) biofeedback (also called Neurofeedback): A biofeedback method intended to gain control of brain wave activity with the goal of improving a medical or psychological condition.

Electromyography (EMG) biofeedback: A biofeedback method intended to gain control of muscle tension.

Galvanic skin response biofeedback: A biofeedback method intended to gain control of body sweating.

Heart variability biofeedback: A biofeedback method intended to gain control of heart rate.

Thermal biofeedback: A biofeedback method intended to gain control of body temperature.

Peer Reviewed Publications:

1. Abdelrahman EM, Abdel Ghafar MA, Selim AO, et al. Biofeedback versus bilateral transcutaneous posterior tibial nerve stimulation in the treatment of functional non-retentive fecal incontinence in children: a randomized controlled trial. J Pediatr Surg. 2021; 56(8):1349-1355.
2. 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.
3. 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.
4. 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.
5. 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.
6. Blanchard BE, Johnson M, Campbell SB, et al. Minimal important difference metrics and test-retest reliability of the PTSD Checklist for DSM-5 with a primary care sample. J Trauma Stress. 2023; 36(6):1102-1114.
7. 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; 5(1):5-11.
8. 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.
9. 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.
10. 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.
11. Cortese S, Ferrin M, Brandeis D, et al. Neurofeedback for attention-deficit/hyperactivity disorder: meta-analysis of clinical and neuropsychological outcomes from randomized controlled trials. J Am Acad Child Adolesc Psychiatry. 2016; 55(6):444-455.
12. 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.
13. 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.
14. 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.
15. Duric NS, Assmus J, Gundersen D, et al. Multimodal treatment in children and adolescents with attention-deficit/hyperactivity disorder: a 6-month follow-up. Nord J Psychiatry. 2017; 71(5):386-394.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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.
21. Gevensleben H, Holl B, Albrecht B, et al. Is neurofeedback an efficacious treatment for ADHD? A randomised controlled clinical trial. J Child Psychol Psychiatry. 2009; 50(7):780-789.
22. Gevensleben H, Holl B, Albrecht B, et al. Neurofeedback training in children with ADHD: 6-month follow-up of a randomised controlled trial. Eur Child Adolesc Psychiatry. 2010; 19(9):715-724.
23. Ghazavi Dozin SM, Mohammad Rahimi N, Aminzadeh R. Wii fit-based biofeedback rehabilitation among post-stroke patients: a systematic review and meta-analysis of randomized controlled trial. Biol Res Nurs. 2024; 26(1):5-20.
24. Gninenko N, Trznadel S, Daskalou D, et al. Functional MRI neurofeedback outperforms cognitive behavioral therapy for reducing tinnitus distress: a prospective randomized clinical trial. Radiology. 2024; 310(2):e231143.
25. 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.
26. 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.
27. 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. 2020b; 24(70):1-144.
28. 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. 2020a; 371:m3719.
29. 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.
30. 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.
31. 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.
32. 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.
33. Kilijn 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.
34. 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.
35. 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.
36. 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.
37. Lee EJ, Jung CH. Additive effects of neurofeedback on the treatment of ADHD: a randomized controlled study. Asian J Psychiatr. 2017; 25:16-21.
38. 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; 10:54-62.
39. 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.
40. 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.
41. 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.
42. 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.
43. Meuret A, Wilhelm F, Roth W. Respiratory feedback for treating panic disorder. J Clinical Psychol. 2004; 60 (2):197-207.
44. 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.
45. 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.
46. 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.
47. 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.
48. Nestoriuc Y, Martin A. Efficacy of biofeedback for migraine: a meta-analysis. Pain. 2007; 128(1-2):111-127.
49. 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.
50. 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.
51. Nolan RP, Floras JS, Harvey PJ, et al. Behavioral neurocardiac training in hypertension: a randomized, controlled trial. Hypertension. 2010; 55(4):1033-1039.
52. 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.
53. 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.
54. 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.
55. 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.
56. Purper-Ouakil D, Blasco-Fontecilla H, Ros T, et al. Personalized at-home neurofeedback compared to long-acting methylphenidate in children with ADHD: NEWROFEED, a European randomized noninferiority trial. J Child Psychol Psychiatry. 2022; 63(2):187-198.
57. 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.
58. Roy R, de la Vega R, Jensen MP, et al. Neurofeedback for pain management: a systematic review. Front Neurosci. 2020; 14:671.
59. 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.
60. 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.
61. 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.
62. 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.
63. 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.
64. Scott WC, Kaiser D, Othmer S, et al. Effects of an EEG biofeedback protocol on a mixed substance abusing population. Drug Alcohol Abuse. 2005; 31(3):445-469.
65. 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.
66. Sheinfeld Gorin S, Krebs P, Badr H, et al. Meta-analysis of psychosocial interventions to reduce pain in patients with cancer. J Clin Oncol. 2012; 30(5):539-547.
67. 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.
68. Silver N. Headache (chronic tension-type). Am Fam Physician. 2007; 76(1):114-116.
69. 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).
70. 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.
71. 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.
72. 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.
73. Stubberud A, Varkey E, McCrory DC, et al. Biofeedback as prophylaxis for pediatric migraine: a meta-analysis. Pediatrics. 2016; 138(2):e20160675.
74. 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.
75. 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.
76. 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.
77. 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.
78. van Reijn-Baggen DA, Elzevier HW, Putter H, et al. Pelvic floor physical therapy in patients with chronic anal fissure: a randomized controlled trial. Tech Coloproctol. 2022; 26(7):571-582.
79. 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.
80. Verhagen AP, Damen L, Berger MY, et al. Lack of benefit for prophylactic drugs of tension-type headache in adults: a systematic review. Fam Pract. 2010; 27(2):151-165.
81. Wang L, Liu R, Wang Y, et al. Effectiveness of a biofeedback intervention targeting mental and physical health among college students through speech and physiology as biomarkers using machine learning: a randomized controlled trial. Appl Psychophysiol Biofeedback. 2024; 49(1):71-83
82. Weinstein MM, Collins S, Quiroz L, et al. Multicenter randomized controlled trial of pelvic floor muscle training with a motion-based digital therapeutic device versus pelvic floor muscle training alone for treatment of stress-predominant urinary incontinence. Female Pelvic Med Reconstr Surg. 2022 ;28(1):1-6.
83. 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..
84. 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.
85. 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.
86. 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.
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88. 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.
89. 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.
90. 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:

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1. National Institute of Neurologic Disorders and Stroke (NINDS). Headache information page. Last reviewed on November 22, 2024. Available at: https://www.ninds.nih.gov/Disorders/All-Disorders/Headache-Information-Page. Accessed on April 03, 2025.

Biofeedback
EEG Biofeedback (Neurofeedback)
Neurofeedback
Prism
Renovia leva^®

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