Coverage Policy Manual
Policy #: 1998044
Category: Medicine
Initiated: February 1998
Last Review: July 2023
  Neurofeedback
Description:
Various disorders involve abnormal brain activity, including autism spectrum disorder, insomnia and sleep disorders, learning disabilities, Tourette syndrome, traumatic brain injury, seizure disorders, premenstrual dysphoric disorder, menopausal hot flashes, depression, stress management, panic and anxiety disorders, posttraumatic stress disorder, substance abuse disorders, eating disorders, migraine headaches, stroke, Parkinson disease, fibromyalgia, tinnitus, and attention-deficit/hyperactivity disorder (ADHD).
 
Neurofeedback is being investigated for the treatment of a variety of disorders. Neurofeedback may be conceptualized as a type of biofeedback that has traditionally used the electroencephalogram (EEG) as a source of feedback data. Neurofeedback differs from established forms of biofeedback in that the information fed back to the patient (via EEG tracings, functional magnetic resonance imaging, near-infrared spectroscopy) is a direct measure of global neuronal activity, or brain state, compared with feedback of the centrally regulated physiologic processes, such as tension of specific muscle groups or skin temperature. The patient may be trained to increase or decrease the prevalence, amplitude, or frequency of specified EEG waveforms (eg, alpha, beta, theta waves), depending on the changes in brain function associated with the particular disorder. It has been proposed that training of slow cortical potentials (SCPs) can regulate cortical excitability and that using the EEG as a measure of central nervous system functioning can help train patients to modify or control their abnormal brain activity. Upregulating or downregulating neural activity with real-time feedback of functional magnetic resonance imaging signals is also being explored.
 
Two EEG-training protocols (training of SCPs, theta/beta training) are typically used in children with ADHD. For training of SCPs, surface-negative and surface-positive SCPs are generated over the sensorimotor cortex. Negative SCPs reflect increased excitation and occur during states of behavioral or cognitive preparation, while positive SCPs are thought to indicate a reduction of cortical excitation of the underlying neural networks and appear during behavioral inhibition. In theta/beta training, the goal is to decrease activity in the EEG theta band (4-8 Hz) and increase activity in the EEG beta band (13-20 Hz), corresponding to an alert and focused but relaxed state. Alpha-theta neurofeedback is typically used in studies on substance abuse. Neurofeedback protocols for depression focus on alpha interhemispheric asymmetry and theta/beta ratio within the left prefrontal cortex. Neurofeedback for epilepsy has focused on sensorimotor rhythm up-training (increasing 12-15 Hz activity at motor strip) or altering SCPs. It has been proposed that learned alterations in EEG patterns in epilepsy are a result of operant conditioning and are not conscious or voluntary. A variety of protocols have been described for the treatment of migraine headaches.
 
Regulatory Status
A number of EEG feedback systems (EEG hardware and computer software programs) have been cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process. For example, the BrainMaster™ 2E (BrainMaster Technologies) is "…indicated for relaxation training using alpha EEG Biofeedback. In the protocol for relaxation, BrainMaster™ provides a visual and/or auditory signal that corresponds to the patient's increase in alpha activity as an indicator of achieving a state of relaxation." Although devices used during neurofeedback may be subject to FDA regulation, the process of neurofeedback itself is a procedure, and, therefore, not subject to FDA approval.
 
FDA product codes: HCC, GWQ.
Policy/
Coverage:
Effective July 2021
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Neurofeedback does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, neurofeedback is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective Prior to July 2021
 
Neurofeedback is not covered based on benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For contracts without primary coverage criteria, neurofeedback is considered investigational.  Investigational services are an exclusion in the member certificate of coverage.
Rationale:
2002-2004 Update
A literature search, focusing on articles published between 1998 and October 2004 did not identify any articles that would change the coverage policy statement. A total of 5 relevant articles were identified. One article consisted of an uncontrolled case series of 111 subjects with panic disorder.  The patients received neurofeedback and metacognitive strategies. In most instances, the neurofeedback was used to identify when the subject was focused, thought to be the most optimal time for subsequent metacognitive therapy. This uncontrolled nature of the study prohibits the assessment of the contribution of neurofeedback to the overall treatment effect and prohibits assessment of a possible placebo effect. The second article was a case study of 3 patients with epilepsy, and the third article addressed methodologic issues only.  The fourth article reported on a randomized controlled trial on neurofeedback for relaxation conducted by Egner and colleagues who found that alpha/theta feedback resulted in greater theta/alpha ratios, as compared to mock feedback suggesting enhanced relaxation.  However, there was no difference in subjective reports as both groups reported significantly lower levels of activation after training sessions. The fifth article consisted of a comparative study of neurofeedback and methylphenidate therapy in 34 patients with attention deficit disorder.  In this nonrandomized study, patients in both groups reported improvements in various measures of attention. The lack of controlled trials does not permit scientific conclusions regarding the efficacy of neurofeedback for any indication; therefore, the policy statement is unchanged.
 
In addition, relevant practice guidelines were also searched. The American Psychiatric Association has published guidelines focusing on the treatment of panic disorder; neurofeedback is not included in their study. The American Academy of Pediatrics has published guidelines regarding the treatment of attention deficit/hyperactivity disorder. Neurofeedback is not mentioned in these guidelines. Finally, a search of the American Psychological Association Web site found no references to neurofeedback.
 
2006 Update
A review of the peer-reviewed literature on MEDLINE for the period of October 2004 through June 2006 did not identify any clinical trial publications that would change the conclusions reached above. Therefore, the coverage policy statement is unchanged. In a June 2005 review/meta-analysis, Monastra and colleagues used criteria from the Association for Applied Psychophysiology and Biofeedback (AAPB) and the International Society for Neuronal Regulation (ISNR) to assess the clinical efficacy of EEG biofeedback for attention deficit/hyperactivity disorder (ADHD). The authors concluded that EEG biofeedback for ADHD was ranked at Level 3 or "probably efficacious" on a scale of 1 to 5, 1 being not empirically supported and 5 being efficacious and specific. The authors noted that benefits were reported in the 5 randomized group studies (totaling 214 patients) included in their analysis; however, the ranking for EEG biofeedback for ADHD was based on the need for further studies controlled for patient and therapist factors that could unduly influence outcomes. In a controlled study of 120 substance abuse patients being treated on an inpatient basis, Scott et al concluded that patients randomized to EEG biofeedback had better rates of drug abstinence at 1-year follow-up and remained in treatment longer than patients given additional treatment time equal to time spent in EEG biofeedback sessions (77% vs. 44%, and an average of 135 days vs. 101 days p <0.005).  After 46 treatment days, the authors also reported that the Test of Variables of Attention (TOVA) significantly improved and that 5 of 10 scales of the Minnesota Multiphasic Personality Inventory-2 significantly differed in a positive manner in the EEG biofeedback group. While the authors indicate that the patients and testers were blind to group assignment for TOVA and MMPI testing, it is not clear how patients could be kept unaware of their assigned treatment groups while living in a residential treatment facility. In addition, the authors do not describe the additional treatment given to the control group. These factors of blinding and additional treatment could confound outcomes. Moreover, abstinence was not confirmed by urine or serum testing. Therefore, firm conclusions from this study cannot be made, and 1 trial of 120 patients is not sufficient, given the prevalence of this condition. The American Psychiatric Association’s published guidelines on the treatment of panic disorder and substance abuse do not address neurofeedback.  The American Academy of Pediatrics Web site indicates EEG biofeedback has not been proven to work in the treatment of ADHD.  Finally, the American Psychological Association Web site briefly discusses neurofeedback but does not specifically make a recommendation for or against it.
 
2007 Update
A search of the MEDLINE database for the period of July 2006 to August 2007 did not identify any studies that would change the conclusions reached above. One small (n=6) quasi-randomized, double-blind pilot study examined whether increasing peak alpha frequency would improve cognitive performance in older adults (70–78 years of age).  Control subjects were trained to increase alpha amplitude or shown playback of one of the experimental subject’s sessions. Compared to controls, the experimental group showed improvements in speed of processing for 2 of 3 cognitive tasks (Stroop, Go/No-Go) and executive function in 2 tasks (Go/No-Go, n- back); other functional measures, such as memory, were decreased relative to controls.
 
Another study examined brain activity following neurofeedback in 15 children with attention-deficit/hyperactivity disorder (ADHD).  The experimental subjects learned to inhibit the amplitude of theta waves (4–7 Hz) and increase amplitude of beta waves (15–18 Hz). Five children with ADHD were randomized to a non-treatment control condition. Functional magnetic resonance imaging revealed increased activation of the right anterior cingulate cortex, an area related to selective attention that had previously shown to be altered in children with ADHD. However, it could not be determined whether the change in brain function was related to the specific neural training program (decreasing the amplitude of theta waves and increasing the amplitude of beta waves) or to the additional attentional training received by the experimental group. Questions also remain about the effect of this training on cognitive and behavioral outcomes in children with ADHD.
 
There is insufficient evidence from the available peer-reviewed literature to conclude that EEG biofeedback therapy is effective for the treatment of disorders such as ADD, ADHD, epilepsy, insomnia, depression, mood disorders, posttraumatic stress disorder, alcoholism, drug addiction, or menopausal symptoms. Although several studies reported a reduction in symptoms of ADHD and one study documented a decrease in seizure incidence in patients with epilepsy, these studies had numerous methodological flaws and are insufficient to support conclusions regarding the efficacy of EEG biofeedback training.
 
Neurofeedback therapy for any diagnosis/condition, including, but not limited to, ADD, ADHD, epilepsy, insomnia, generalized anxiety disorder, depression, mood disorders, post-traumatic stress disorder, alcoholism, drug addiction, and menopausal symptoms is not covered because the do not meet member benefit certificate Primary Coverage Criteria for effectiveness based on the published review of an independent technology assessment organization (Hayes, Inc).
 
2010 Update
A review of the literature has been conducted through August 2010.  There was no new literature identified that would prompt a change in the coverage statement.
 
2012 Update
A search of the MEDLINE database was conducted through September 2012.  There was no new information identified that would prompt a change in the coverage statement. The following is a summary of the key literature identified.
 
ADHD
A 2011 review of complementary medicine for ADHD indicates that there is only one large randomized trial (Gevensleben et al., reviewed above) that found a significant benefit (i.e., with a moderate effect size of 0.6) of neurofeedback for children with ADHD (Skokauskas, 2011). In comparison, effect sizes in studies that used medication were around 0.8 for methylphenidate and around 1.2 for amphetamine. Three additional small RCTs have been identified which found no significant difference between neurofeedback and either attention skills training, placebo training, or biofeedback relaxation training (Gevensleben, 2012).  Comparison with biofeedback relaxation training suggests that non-specific factors such as a structured learning environment may contribute to the effects of neurofeedback (Bakhshayesh, 2011).
 
Parkinson’s Disease
Subramanian et al. conducted a “proof of principle” study to determine whether fMRI-guided activity increase in the supplementary motor area (SMA) cortex complex would result in improved motor function in patients with early stage Parkinson’s disease (Subramanian, 2011). Patients were instructed to practice the strategy/imagery that was used during the initial neurofeedback (n=5) or control imagery session (n=5) for 2-6 months at home. At follow-up, the patients in the fMRI neurofeedback group showed higher activation than imagery control patients in several brain regions and improved motor speed (finger tapping) and clinical ratings of motor symptoms. The imagery control patients showed no control of SMA activation and no motor improvement.
 
Migraine Headaches
Walker reported quantitative EEG (QEEG) for the treatment of migraine headaches in 46 patients (Walker, 2011). Results were compared with 25 patients who chose not to do neurofeedback and continued anti-migraine drug therapy. Since baseline QEEG assessment (all 71 patients) showed a greater amount of the high-frequency beta band (21-30 Hz); the 5 neurofeedback sessions focused on increasing 10-Hz activity and decreasing 21-30 Hz targeted individually to brain areas where high-frequency beta was abnormally increased. Patient diaries of headache frequency showed a reduction in migraines in a majority of patients in the QEEG group but not the drug-therapy group. Fifty-four percent reported complete cessation of migraines over 1 year, with an additional 39% reporting a greater than 50% reduction. In comparison, no patients in the drug-therapy group reported a cessation of headaches, and 8% had a reduction in headache frequency of greater than 50%. Randomized sham-controlled trials are needed to adequately evaluate this treatment approach.
 
Practice Guidelines and Position Statements
The International Society for Neurofeedback & Research published a 2011 position paper on standards of practice for neurofeedback and neurotherapy (Hammond, 2011). Issues discussed include competency, qualifications of practitioners, scope of practice, informed consent, pretreatment assessment, standards for remote training, recordkeeping and billing, accountability, standards for practitioner training and qualifications to be trained, adequate supervision and coaching of training sessions, ethical advertising, standards for professional societies, and standards for those who sell and manufacture neurofeedback equipment.
 
Clinical guidelines on behavioral and psychosocial interventions for Tourette syndrome and other tic disorders were published in 2011 by the European Society for the Study of Tourette Syndrome. The guidelines state that neurofeedback is still experimental (Verdellen, 2011).
 
2013 Update
A search of the MEDLINE database through August 2013 did not reveal any new literature that would prompt a change in the coverage statement. Two randomized controlled trials were identified and summarized below.
 
In 2013, Koprivova et al. reported a double-blind randomized sham-controlled trial of independent component neurofeedback in 20 patients with obsessive-compulsive disorder (Koprivova, 2013). Independent component neurofeedback is based on the individual diagnosis of pathological EEG sources and was directed at downtraining of abnormally high activity. All patients were hospitalized and participated in a 6-week standard treatment program that included cognitive-behavioral therapy and 25 neurofeedback or sham biofeedback sessions. The neurofeedback group showed greater reduction of compulsions compared to the sham group (56% vs. 21%). However, clinical improvement was not associated with a change in EEG.
 
In 2012, Duric et al. reported a comparative study of neurofeedback versus methylphenidate in 91 children with ADHD (Duric, 2012). The children were randomized into 3 groups, consisting of 30 sessions of neurofeedback, methylphenidate, or a combination of neurofeedback and methylphenidate. The neurofeedback sessions focused on increasing cortical beta activity and decreasing theta activity. Parental evaluations found improvements in ADHD core symptoms for all 3 groups, with no significant differences between groups. Alternative reasons for improvement with neurofeedback include the amount of time spent with the therapist and cognitive-behavioral training introduced under neurofeedback.
 
2014 Update
A literature search conducted through June 2014 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Randomized Controlled Trials
 In 2013, van Dongen-Boomsma et al reported a well-conducted, randomized, assessor and patient-blinded, placebo-controlled trial of neurofeedback in 41 children age 8- 15 years (van Dongen-Boomsma, 2013). Only children with an EEG that deviated from the normative database were included in the study. Children in the feedback group were given positive feedback for increasing activity in the beta band and decreasing theta activity, while children in the placebo-control group received feedback based on a random EEG signal. Outcomes were assessed by structured interview with the parents, teacher reports, and by the investigator with the Clinical Global Impressions-Improvement scale. Both groups improved over time in ADHD symptoms and clinical scores, with similar improvement in the 2 groups.
 
Steiner et al randomized 104 children with ADHD age 7-11 years to receive neurofeedback, cognitive training, or a no-intervention control condition in their elementary school (Steiner, 2014). Both the neurofeedback and cognitive therapies were administered with commercially available computer programs (45-min sessions 3 times per week), monitored by a trained research assistant. The neurofeedback EEG sensor was embedded in a standard bicycle helmet with the grounding and reference sensors located on the chin straps on the mastoids. No data was presented on the technical performance of this system. There were some differences in baseline measures between the groups, although these differences were not large. The slope of the change in scores over time was compared between groups. Children in the neurofeedback group showed a small improvement on the Conners 3-Parent Assessment Report (effect size [ES] = 0.34 for inattention, ES = 0.25 for executive functioning, ES = 0.23 for hyperactivity/impulsivity) and subscales of the Behavior Rating Inventory of Executive Function Parent Form (BRIEF global executive composite, ES=0.23) when compared with baseline. Interpretation of these findings is limited by the use of a no-intervention control group and lack of parental blinding. Evaluator blinded classroom observation (Behavioral Observation of Students in Schools) found no sustained change with a linear growth model but a significant improvement with a quadratic model. No between group difference in change in medication was observed at the 6-month follow-up.
 
 
There are two moderate-sized RCTs that have examined neurofeedback in comparison with attention skills training or cognitive therapy. Both studies found a small benefit of neurofeedback, although interpretation of one of the studies is limited by the lack of parental blinding and differences in baseline measures, along with a lack of information on the technical performance of the system. A smaller well conducted, sham controlled study found no benefit of neurofeedback on standard ADHD outcome measure. Studies that have attempted to use active controls have suggested that at least part of the effect of neurofeedback may be due to attention skills training, relaxation training, and/or other non-specific effects. Larger sham controlled studies are needed to evaluate whether neurofeedback (alone or in combination with other treatments) has beneficial effects for children with ADHD. Durability of any observed effect also needs to be evaluated.
 
Practice Guidelines and Position Statements
The American Academy of Pediatrics published a 2011 clinical practice guideline for the diagnosis, management, evaluation and treatment of attention-deficit/hyperactivity disorder in children and adolescents (American Academy of Pediatrics, 2011). They state that although electroencephalographic biofeedback is used clinically, it is not FDA approved for the treatment of ADHD and needs further research.
 
The Institute for Clinical Systems Improvement (ICSI) released a 2012 revision of their 2010 guideline: diagnosis and management of attention deficit hyperactivity disorder in primary care for school age children and adolescents (ICSI, 2012). The guideline states that neurofeedback has been demonstrated in one randomized, controlled clinical trial to be significantly better than computerized attention skills training. ADHD symptoms were moderately improved, however, long-term benefits have not been definitely proven, and neurofeedback lacks sufficient research support. They conclude that treatment responses have not reached the level shown with psychostimulant medications; therefore neurofeedback cannot be recommended as an alternative to medication use for ADHD.
 
The National Institute for Health and Care Excellence (NICE) issued a 2013 clinical guideline; Autism; The management and support of children and young people on the autism spectrum (NICE, 2014). They stated the following treatments were considered but are not recommended: neurofeedback, auditory integration training to manage speech and language problems, omega-3 fatty acids to manage sleep problems, secretin, chelation, and hyperbaric oxygen therapy in any context.
 
2015 Update
 A literature search conducted through May 2015 did not reveal any new information that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
A 2014 systematic review of neurofeedback in children with ADHD included 5 studies with a total of 263 patients (Micoulaud-Franchi, 2014).  The active treatment was theta/beta ratio training or slow cortical potential training. Control treatments included cognitive remediation, sham neurofeedback, or electromyography (EMG) biofeedback. Meta-analysis found a significant benefit from parent (probably not blinded) assessment on the overall ADHD score (standardized mean difference [SMD] = -0.49), the hyperactivity/impulsivity score (SMD = -0.34), and the inattention score (SMD = -0.46). This is considered to be a moderate effect size. For teacher assessment, which is more likely to be blinded, only the inattention score showed significant improvement with neurofeedback (SMD = -0.30).
 
In a 2014 publication of self-reports from this study, there was no improvement in attention, hyperactivity, or school achievement when adjusted for age and sex (Duric, 2014).  Only the neurofeedback group showed a significant improvement in self-reported school performance.
 
Ongoing and Unpublished Clinical Trials
A search of www.ClinicalTrials.gov identified RCTs of neurofeedback for a wide variety of conditions, including ADHD, Tourette syndrome, central neuropathic pain, dementia, fibromyalgia, stroke, Parkinson disease, postoperative pain, PTSD, and premenstrual dysphoric disorder.
 
NCT01879644 Neurofeedback Study ADHD; planned enrollment 120; projected completion date December 2016.
 
NCT02148770 Modulating Functional Connectivity Between Eating-related Brain Areas by Neurofeedback; planned enrollment 120; projected completion date May 2017.
 
NCD01841151 Does Neurofeedback and Working Memory Training Improve Core Symptoms of ADHD in Children and Adolescents? A Comparative, Randomized and Controlled Study; planned enrollment 220; projected completion date December 2017.
 
NCT02251743 Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD; planned enrollment 149; projected completion date December 2019.
 
2016 Update
A literature search conducted through April 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Bink and colleagues compared neurofeedback and treatment as usual (TAU) in a 2015 non-blinded multicenter RCT (Bink, 2015). Adolescents with clinical ADHD symptoms were stratified by age and randomized to receive theta/sensorimotor rhythm neurofeedback plus TAU (n=59) or TAU only (n=31). TAU could include stimulant medication and behavioral interventions such as cognitive behavioral therapy and counseling for patients or their parents. These treatments were comparable between the groups. Neurofeedback sessions were given 2 to 3 times a week for 25 weeks. Primary outcomes included the ADHD-rating scale, Youth Self Report, and Child Behavior Checklist. Behavioral problems decreased equally for both groups, and neurofeedback plus TAU was not more effective than TAU alone.
 
Ongoing and Unpublished Clinical Trials
A search of www.ClinicalTrials.gov identified RCTs of neurofeedback for a wide variety of conditions, including ADHD, Tourette syndrome, central neuropathic pain, dementia, fibromyalgia, stroke, Parkinson disease, postoperative pain, PTSD, and premenstrual dysphoric disorder. Some of the larger trials that might influence these are listed below:
 
Ongoing
(NCT02146495) Pain and Sleep Quality Measures Before and After a Course of EEG Neurofeedback in Fibromyalgia Patients; planned enrollment 200; completion date 2016.
 
(NCT01879644 Neurofeedback Study ADHD; planned enrollment 120; completion date 2016.
 
(NCT01841151) Does Neurofeedback and Working Memory Training Improve Core Symptoms of ADHD in Children and Adolescents? A Comparative, Randomized and Controlled Study; planned enrollment 220; completion date December 2017.
 
(NCT02251743) Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD; planned enrollment 149; completion date December 2019.
 
Unpublished
(NCT01883765) Efficacy of a Neurofeedback Treatment in Adults With ADHD: a Double-blind Randomized Placebo-controlled Study; planned enrollment 105; completion date September 2015.
 
2017 Update
A literature search conducted using the MEDLINE database through June 2017 did not reveal any new literature that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2016, Cortese et al, on behalf of the European ADHD Guidelines Group, reported a meta-analysis of 13 RCTs (total N=520 participants) on neurofeedback for ADHD.2 When outcomes were reported by assessors who were the least likely to be blinded (parents), there were small-to-moderate effects for total symptoms, inattention, and hyperactivity/impulsivity. However, the effects were not significant when the likelihood of blinding was higher (teacher reported). There were no benefits on objective measures of attention and inhibition.
 
In 2016, Gelade et al on reported a randomized comparison of neurofeedback (n=39) with either stimulants (n=36) or physical activity (n=37).8 Neurofeedback and physical activity were balanced for the number and duration of sessions (3 sessions a week for 10-12 weeks). The trial was adequately powered to detect a medium effect size. Intention-to-treat analysis with last observation carried forward showed an improvement in parent-reported behavior for all interventions, while teachers, who were not blinded to treatment, reported a decrease of ADHD symptoms only for the methylphenidate group compared to placebo.
 
In 2016, de Ruiter et al reported a multicenter, triple-blinded RCT of neurofeedback in 80 pediatric brain tumor survivors who had cognitive impairments.13 The specific neurofeedback module was based on individual EEG, and participants, parents, trainers, and researchers handling the data were blinded to assignment to the active or sham neurofeedback module. At the end of training and at 6-month follow-up, there were no significant differences between the neurofeedback and sham feedback groups on the primary outcome measures for cognitive performance, which included attention, processing speed, memory, executive functioning, visuomotor integration, and intelligence.
 
2018 Update
A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.  
 
Alegria et al investigated the efficacy of real-time functional magnetic resonance neurofeedback (rtfMRI-NF) in adolescents with ADHD (Alegria, 2017). This single-blind RCT consisted of 31 boys with ADHD (12-17 years old) who, over 2 weeks, underwent an average of 11 rtfMRI-NF sessions. The boys were assigned to rtfMRI-NF testing of the right inferior prefrontal cortex (n=18) or to a control group (n=13); testing of the left parahippocampal gyrus. The rtfMRI-NF testing sessions were visually engaging, and patients were asked to interact with the visuals but given very little coaching. Feedback was provided through video and images. Another session without feedback tested learning retention. The primary outcome measure was the ADHD Rating Scale, Version IV, a standard tool for assessing ADHD symptoms according to the Diagnostic and Statistical Manual of Mental Disorders; the secondary outcome measure was the revised Conners’ Parent Rating Scale for ADHD (Dupaul, 1998.) Both assessment tools were rated by parents. ADHD-related difficulties and functional impairments were assessed with the Weekly Parent Ratings of Evening and Morning Behavior−Revised and the Columbia Impairment Scale−Parent version, respectively. Active and control groups did not differ by type of ADHD-prescribed medication (p=0.3). Groups did not differ in their rtfMRI-NF performance score gain between final and baseline rtfMRI-NF testing sessions (mean prefrontal cortex score, 2.22; mean parahippocampal gyrus score, 10.00; p=0.43). Mean ADHD Rating Scale, Version IV scores were 36.72 and 37.77 in the prefrontal cortex and parahippocampal gyrus groups, respectively (p=0.78). This proof-of-concept study was limited by its sample size, population bias (only males), and rtfMRI-NF testing session completion rates.
 
In a triple-blind RCT conducted in Germany, Schönenberg et al identified 113 adults with ADHD and randomized them to neurofeedback (n=37) or sham neurofeedback (n=38) or meta-cognitive therapy (MCT; n=38) (Schönenberg, 2017). Patients in the neurofeedback group received 30 verum θ-to-β neurofeedback sessions over 15 weeks; sham neurofeedback patients received 15 sham followed by 15 verum θ-to-β neurofeedback sessions over 15 weeks, and the MCT patients received 12 sessions over 12 weeks. Patients in the neurofeedback and sham neurofeedback groups were masked to treatment assignment; however, patients in the MCT group knew their treatment assignment. The primary outcome was symptom score on the Conners’ Adult ADHD Rating Scale, which was measured before, during (week 8), and after treatment (at week 16 and at 6 months). At the 6-month follow-up, patients in all treatment groups reported a reduction in ADHD symptoms (B = -2.58; 95% confidence interval, -3.48 to -1.68; p<0.001; neurofeedback vs sham neurofeedback, B = -0.89; 95% confidence interval, -2.14 to 0.37; p=0.168; neurofeedback vs MCT, -0.30; 95% confidence interval, -1.55 to 0.95; p=0.639). Reviewers concluded that neurofeedback training is not superior to sham or MCT but that all 3 treatments have merit in managing ADHD.
 
In a blinded RCT, Zilverstand et al investigated the utility of rtfMRI-NF when used to target the dorsal anterior cingulate cortex, which is a part of the brain that harnesses cognition and motor control, in adults with ADHD (Zilverstand, 2017). Trialists sought to use rtfMRI-NF training to reduce clinical symptoms and improve cognitive functioning. Thirteen individuals (7 active, 6 control) underwent 4 weekly training of mental exercises designed to help them learn how to upregulate dorsal anterior cingulate cortex activation. The analysis of self-regulation performance during the training runs revealed learning effects in both groups. There was no significant difference between control and an active group (p=0.38), but both groups showed significant improvements in activation level between the second and the third sessions; moreover, activation levels remained to stay high until training completion (p<0.05). Small sample size limited this trial, though results suggested neurofeedback training might improve cognitive function.
 
The American Academy of Pediatrics published clinical practice guidelines on the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. AAP stated that although electroencephalogram biofeedback is used clinically, it is not approved by the U.S. Food and Drug Administration for the treatment of ADHD and requires further research. In a 2012 report, AAP revised its position on biofeedback, designating it as a “Level 1 – Best Support” treatment for children with ADHD (AAP, 2018.) In 2014, AAP further supported its position, stating that neurofeedback “can contribute to lasting improvements” for children with ADHD, citing the Steiner et al 5 article (AAP, 2014).
 
The National Institute for Health and Care Excellence issued guidance on management and support of children on the autism spectrum (NIHCE, 2013). The Institute stated that the number of treatments were considered but are not recommended, including neurofeedback.
 
2019 Update
A literature search was conducted through June 2019.  There was no new information identified that would prompt a change in the coverage statement.  
 
2020 Update
A literature search was conducted through June 2020.  There was no new information identified that would prompt a change in the coverage statement.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2021. No new literature was identified that would prompt a change in the coverage statement.  
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Hasslinger et al published a multi-arm, pragmatic, RCT [NCT01841151] in 202 children and adolescents with ADHD that evaluated the efficacy of 2 neurofeedback treatments (slow cortical potential [SCP] and Live Z-score) compared to working-memory training (active comparator) and treatment as usual (passive comparator) (Hasslinger, 2022). Only the inattention and hyperactivity/impulsivity Conners subscales were reported by Hasslinger et al. Neither neurofeedback treatment was superior to working-memory training for these outcome measures. Significant differences between SCP and treatment as usual were observed post-treatment for teacher- and parent-rated inattention, with no difference for other outcome measures at either timepoint. A statistically significant difference in Live Z-score over treatment as usual was only observed at the 6-month endpoint for teacher-rated inattention and hyperactivity/impulsivity. No other differences between Live Z-score and treatment as usual were observed. Secondary outcomes in this study included measures of teacher- and parent-rated executive function and self-assessed health-related quality of life using the Behavior Rating of Executive Functions (BRIEF) and KIDSCREEN-27 scales, respectively. There were no consistent differences between neurofeedback interventions and control interventions for these outcomes except for teacher-assessed executive function at 6 months follow-up, which found both neurofeedback interventions superior to working-memory training and treatment as usual.
 
A RCT published by Purper-Ouakil et al included 149 children between the ages of 7-13 with ADHD (Purper-Ouakil, 2022). The intervention consisted of at-home neurofeedback (NF) training versus methylphenidate in the treatment of children with ADHD. The neurofeedback group resulted in -9.21 after 30 days, and the methylphenidate group resulted in -17.3.
 
A few small studies (case reports, case series, comparative cohorts, small RCTs) of neurofeedback for the following conditions have recently been identified.:
    • Chronic pain (Hesam, 2022)
    • Parkinson disease (Tinaz, 2022: Anil, 2021)
    • Schizophrenia (Markiewicz, 2021)
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
An RCT by Gabrielsen et al randomized adults with substance abuse disorders enrolled in outpatient abuse programs to either 20 sessions (30 minutes each) of infralow (ILF) neurofeedback plus standard of care, or standard of care alone, over a mean of 5 months (Gabrielsen, 2022). At the end of the intervention period, both groups demonstrated a significant improvement in quality of life scores from baseline, but there was no difference between groups. Restlessness was reportedly significantly lower in the ILF-neurofeedback group compared to standard of care post-treatment, but this was a secondary endpoint, meaning the study was not powered to find differences only in this endpoint. Individuals were not stratified based on drugs of abuse and there was a lack of sham neurofeedback, limiting results.
 
Hong and Park conducted a meta-analysis of 7 RCTs of adults with PTSD treated with neurofeedback (Hong, 2022). Three studies used functional magnetic resonance imaging (fMRI) based neurofeedback and 4 studies used EEG-based neurofeedback. The overall effect of all studies pooled together demonstrated a significant improvement in PTSD symptoms with neurofeedback compared to sham neurofeedback, no treatment, or other treatment. When analyzed by type of neurofeedback, the significant improvement in PTSD symptoms remained with EEG-based neurofeedback, but not with fMRI. Five studies overall assessed anxiety and depression with various validated scales. Overall, there was no significant impact on anxiety and depression with neurofeedback compared to control group. Two studies demonstrated a high risk of performance or detection bias, while all other studies demonstrated overall low risk of bias.
 
A small study of neurofeedback for Cigarette cravings was identified. (Pandria, 2023).
 
The Society for Development and Behavioral Pediatrics (SDBP) published a guideline in 2020 on the assessment and treatment of children and adolescents with complex ADHD (Barbaresi, 2020). Regarding neurofeedback, the guidelines state: "Additional nonpharmacological ADHD interventions have been developed such as cognitive training (e.g., working memory training) and neurofeedback. Although these approaches have shown some improvement in laboratory-based, task-specific outcomes, none have demonstrated sufficient evidence of effectiveness in real-world domains of functioning (e.g., behavior at home and school, academic performance, peer relationships) to recommend them for use in practice with children and adolescents with ADHD."
CPT/HCPCS:
90875Individual psychophysiological therapy incorporating biofeedback training by any modality (face to face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); 30 minutes
90876Individual psychophysiological therapy incorporating biofeedback training by any modality (face to face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); 45 minutes
90901Biofeedback training by any modality
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