Description:
Neurofeedback describes techniques for providing feedback about neuronal activity, as measured by electroencephalogram biofeedback, functional magnetic resonance imaging, or near-infrared spectroscopy, to teach patients to self-regulate brain activity. Neurofeedback may use several techniques in an attempt to normalize unusual patterns of brain function in patients with various psychiatric and central nervous system disorders.

For individuals who have attention-deficit/hyperactivity disorder who receive neurofeedback, the evidence includes randomized controlled trials (RCTs) and a meta-analysis. The relevant outcomes are symptoms, functional outcomes, and quality of life. At least 6 moderately sized RCTs (n range, 90 – 113 patients) have compared neurofeedback with methylphenidate, attention skills training, and/or cognitive therapy. These trials found either small or no benefit of neurofeedback. Studies that used 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 nonspecific effects. Also, the beneficial effects are more likely to be reported by evaluators unblinded to treatment (parents) than by evaluators blinded (teachers) to treatment, suggesting bias in the nonblinded evaluations. A meta-analysis also found no effect of neurofeedback on objective measures of attention and inhibition. Additional research with blinded evaluation of outcomes is needed to demonstrate an effect of neurofeedback on attention-deficit/hyperactivity disorder. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have disorders other than attention-deficit/hyperactivity disorder (e.g., epilepsy, substance abuse, pediatric brain tumors) who receive neurofeedback, the evidence includes case reports, case series, comparative cohorts, and small RCTs. The relevant outcomes are symptoms, functional outcomes, and quality of life. For these other disorders, including psychiatric, neurologic, and pain syndromes, the evidence is poor, and several questions concerning clinical efficacy remain unanswered. Larger RCTs that include either a sham or active control are needed to evaluate the effect of neurofeedback for these conditions. The evidence is insufficient to determine the effects of the technology on health outcomes.

Background 
Disorders of the Central Nervous System
Various of 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.

Treatment
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 (e.g., 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 attention-deficit/hyperactivity disorder. 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 treatment of migraine headaches.

Regulatory Status
A number of EEG-feedback systems (EEG hardware and computer software programs) have been cleared for marketing 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 U.S. Food and Drug Administration (FDA) regulation, the process of neurofeedback itself is a procedure, and, therefore, not subject to FDA approval. FDA product codes: HCC, GWQ. 

Policy:
Neurofeedback is considered investigational and/ or unproven and is therefore considered NOT MEDICALLY NECESSARY.    

Benefit Application
BlueCard/National Account Issues
Neurofeedback may be administered either by a psychiatrist or psychologist.

Rationale

Evidence reviews assess the clinical evidence to determine whether the use of technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Attention-Deficit/Hyperactivity Disorder
Clinical Context and Therapy Purpose
The purpose of neurofeedback is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as behavioral therapy and pharmacologic therapy, in individuals with attention-deficit/hyperactivity disorder (ADHD).

The following PICO was used to select literature to inform this review.

Population
The relevant population of interest is individuals with ADHD.

Attention deficit hyperactivity disorder manifests in children as symptoms of hyperactivity, impulsivity, and/or inattention, and affects cognitive, academic, behavioral, emotional, and social function.1, It is one of the most common neurobehavioral disorders of childhood.

Interventions
The therapy being considered is neurofeedback.

Neurofeedback describes techniques for providing feedback about neuronal activity, as measured by electroencephalogram (EEG) biofeedback, functional magnetic resonance imaging, or near-infrared spectroscopy, to teach patients to self-regulate brain activity. Neurofeedback may use several techniques to normalize unusual patterns of brain function in patients with various psychiatric and central nervous system disorders.

Comparators
Guidelines for treatment of ADHD in children and adolescents generally recommend parent training in behavior management, US Food and Drug Administration (FDA)-approved medications (eg, stimulants), and educational interventions. ADHD also occurs in adults, with a prevalence of approximately 3.4% to 4.4% of US adults. Guidelines for the treatment of ADHD in adults include recommendations for psychoeducation, pharmacotherapy, and cognitive behavioral therapy.2,

Comparators of interest include behavioral therapy and pharmacologic therapy. Treatment includes support groups, cognitive behavioral therapy, anger management, counseling, psychology, psychoeducation, family therapy, and applied behavior analysis. Medications for treatment include stimulants, cognition-enhancing medication, and antihypertensive drugs.

Outcomes
The general outcomes of interest are symptoms, functional outcomes, and quality of life (Tables 1 and 2).

Table 1. Outcomes of Interest for Individuals with ADHD

ADHD: attention-deficit/hyperactivity disorder.

Table 2. Health Outcome Measures Relevant to ADHD in Children and Adolescents

ADHD: attention-deficit/hyperactivity disorder.

In studies of neurofeedback, the duration of intervention was at least 1 month and ranged from 1 to 12 months.4,5,6, Follow-up studies of RCTs that reported longer-term outcomes have reported results at 6 months.^7,8,

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies;
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought
• Within each category of study design, studies with larger sample sizes and longer duration were preferred;
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews with Meta-Analysis
Numerous systematic reviews with meta-analyses have compared neurofeedback versus other treatments for ADHD in children, adolescents, and adults (Tables 3 to 5). ^9,5,6,4,10, Comparators included methylphenidate, biofeedback, cognitive behavioral therapy, cognitive training, or physical activity. The results of these analyses generally demonstrated either small to moderate or no benefit of neurofeedback versus other treatments for ADHD symptoms.

Table 3. Trials Included in Systematic Reviews of Neurofeedback versus Other Treatments for ADHD

ADHD: attention-deficit/hyperactivity disorder.

Table 4. Characteristics of Systematic Reviews and Meta-analyses of Neurofeedback for ADHD

ADHD: attention-deficit/hyperactivity disorder; NR: not reported; RCT: randomized controlled trial.

Table 5. Results of Systematic Reviews and Meta-analyses of Neurofeedback for ADHD

ADHD: attention-deficit/hyperactivity disorder; CI: confidence interval; NR: not reported; SMD: standardized mean difference.

Randomized Controlled Trials Not Included in the Meta-Analyses
Several RCTs not included in the above systematic reviews are described below (Tables 6 to 9).11,7,12,13, Hasslinger et al (2022) published a multi-arm, pragmatic, RCT [NCT01841151] in 202 children and adolescents with ADHD (see Table 6 for trial characteristics) 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).12, The prespecified primary outcome measure14, was the self-, teacher- and parent-reported assessment of ADHD symptoms post-treatment and at 6 months using the Conners 3rd Edition scale. As only the inattention and hyperactivity/impulsivity Conners subscales were reported by Hasslinger et al, its results are not reported in Table 7. 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. Limitations of this RCT are presented in Tables 8 and 9.

Table 6. Characteristics of RCTs of Neurofeedback in ADHD

ADHD: attention-deficit/hyperactivity disorder; BCI: brain-computer interface; EMG: electromyography; NR: not reported; RCT: randomized controlled trial; SCP: slow cortical potential; US: United States.

Table 7. Results of RCTs of Neurofeedback in ADHD

ADHD-RS: attention deficit-hyperactivity disorder-rating scale; BCI: brain-computer interface; CI: confidence interval; Conners 3-P: Conners 3rd Edition-Parent; EMG: electromyography; FBB-HKS: Fremdbeurteilungsbogen für Hyperkinetische Störungen; NR: not reported; RCT: randomized controlled trial; SCP: slow cortical potential.

Table 8. Study Relevance Limitations of RCTs of Neurofeedback in ADHD

ADHD: attention-deficit/hyperactivity disorder; RCT: randomized controlled trial.
The evidence limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 9. Study Design and Conduct Limitations of RCTs of Neurofeedback in ADHD

ADHD: attention-deficit/hyperactivity disorder; RCT: randomized controlled trial.
The evidence limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
^b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
fStatistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Section Summary: Attention Deficit-Hyperactivity Disorder
Several meta-analyses and 5 additional moderately sized RCTs (N range, 144 to 202 patients) have compared neurofeedback with methylphenidate, biofeedback, cognitive behavioral therapy, cognitive training, or physical activity These studies found either small to moderate or no benefit of neurofeedback, and sustained long-term benefit (eg, at 6 to 13 months) has not been consistently demonstrated. Studies using active controls have suggested that at least part of the effect of neurofeedback might be due to attention skills training, biofeedback, relaxation training, and/or other nonspecific effects. Two of the RCTs indicated that any beneficial effects were more likely to be reported by evaluators unblinded to treatment (parents), than by evaluators blinded (teachers) to treatment, which would suggest bias in the nonblinded evaluations. Moreover, a meta-analysis found no effect of neurofeedback on objective measures of attention and inhibition. Additional research with blinded evaluation of outcomes is needed to demonstrate the effect of neurofeedback on ADHD.

Disorders Other Than Attention Deficit-Hyperactivity Disorder
Clinical Context and Therapy Purpose
The purpose of neurofeedback is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as behavioral therapy and pharmacologic therapy, in individuals with disorders other than ADHD.

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is individuals with disorders other than ADHD, including psychiatric, central nervous system, or pain disorders.

Interventions
The therapy being considered is neurofeedback.

Comparators
Comparators of interest include behavioral therapy and pharmacologic therapy.

Outcomes
The general outcomes of interest are symptoms, functional outcomes, and quality of life (Tables 10 and 11).

Table 10. Outcomes of Interest for Individuals with Disorders Other than ADHD

ADHD: attention-deficit/hyperactivity disorder; PTSD: post-traumatic stress disorder.

Table 11. Health Outcome Measures Relevant to Disorders other than ADHD

ADHD: attention-deficit/hyperactivity disorder; PTSD: post-traumatic stress disorder.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies;
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought;
• Within each category of study design, studies with larger sample size and longer duration were preferred;
• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Chronic Insomnia
Systematic Review with Meta-Analysis
A systematic review by Melo et al (2019) included 7 RCTs of biofeedback techniques, including neurofeedback, in the treatment of chronic insomnia.19, The authors identified conflicting results in comparisons of neurofeedback with other cognitive behavioral therapy techniques, placebo, and no treatment. A majority of outcomes demonstrated no significant differences between comparison groups. A majority of studies had a high risk of bias related to blinding of participants and personnel and incomplete outcome data. Characteristics and results from the meta-analysis are summarized in Tables 12 and 13, respectively.

Table 12. Characteristics of a Systematic Review and Meta-analysis of Neurofeedback for Chronic Insomnia

RCT: randomized controlled trial.

Table 13. Results of a Systematic Review and Meta-analysis of Neurofeedback for Chronic Insomnia

CI: confidence interval; NR: not reported. 

Epilepsy
Randomized Controlled Trials
An RCT by Morales-Quezada et al (2019) randomized children with focal epilepsy to sensorimotor rhythm neurofeedback, SCP neurofeedback, or sham neurofeedback for 25 sessions over 5 weeks.16, At the end of the intervention period, only the sensorimotor rhythm neurofeedback group demonstrated significant improvement in the activity switching task and all groups demonstrated significant improvements in quality of life. Characteristics and results from the RCT are summarized in Tables 14 and 15, respectively. Tables 16 and 17 summarize relevant limitations.

Table 14. Characteristics of a Recent RCT of Neurofeedback in Epilepsy

NR: not reported; RCT: randomized controlled trial; SCP: slow cortical potential, SMR: sensorimotor rhythm.

Table 15. Results of a RCT of Neurofeedback in Epilepsy

CI: confidence interval; NR: not reported; RCT: randomized controlled trial; SCP: slow cortical potential; SMR: sensorimotor rhythm.

Table 16. Study Relevance Limitations of a RCT of Neurofeedback in Epilepsy

RCT: randomized controlled trial.
The evidence limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 17. Study Design and Conduct Limitations of a RCT of Neurofeedback

RCT: randomized controlled trial.
The evidence limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
^b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
fStatistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Substance Abuse
Systematic Reviews with Meta-Analyses
A systematic review by Sokhadze et al (2008) of neurofeedback as a treatment for substance abuse disorders described difficulties in assessing the efficacy of neurofeedback and other substance abuse treatments.20, Study shortcomings included a lack of clearly established outcome measures, differing effects of the various drugs, the presence of comorbid conditions, the absence of a criterion standard treatment, and use as an add-on to other behavioral treatment regimens. Reviewers concluded that alpha-theta training, when combined with an inpatient rehabilitation program for alcohol dependency or stimulant abuse, would be classified as level 3 or "probably efficacious." This level is based on beneficial effects shown in multiple observational studies, clinical studies, wait-list control studies, or within-subject or between-subject replication studies. Reviewers also noted that few large-scale studies of neurofeedback in addictive disorders have been reported and that the evidence for alpha-theta training has not been shown to be superior to sham treatment.

Randomized Controlled Trials
An RCT by Gabrielsen et al (2022) 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.21, 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. Characteristics and results from the RCT are summarized in Tables 18 and 19, respectively. Tables 20 and 21 summarize relevant limitations.

Table 18. Characteristics of a Recent RCT of Neurofeedback in Substance Abuse Disorders

ILF: infralow; RCT: randomized controlled trial.

Table 19. Results of a RCT of Neurofeedback in Substance Abuse Disorders

^aMeasured using the QoL-5 scale, ranging from 0.1 to 0.9, where 0.9 is the highest (best) score
^bMeasured using 10 cm visual analog scales
CI: confidence interval; ILF: infralow; QoL: quality of life; RCT: randomized controlled trial. 

Table 20. Study Relevance Limitations of a RCT of Neurofeedback in Substance Abuse Disorders

RCT: randomized controlled trial.
The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4, Enrolled populations do not reflect relevant diversity; 5. Other.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5: Other.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 21. Study Design and Conduct Limitations of a RCT of Neurofeedback in Substance Abuse Disorders

RCT: randomized controlled trial.
The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other.
^b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other.
^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials); 7. Other.
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other.
^f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

Pediatric Brain Tumor Survivors
De Ruiter et al (2016) reported on a multicenter, triple-blind RCT of neurofeedback in 80 pediatric brain tumor survivors who had cognitive impairments.22, 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 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.

Post-Traumatic Stress Disorder
Systematic Reviews with Meta-Analyses
A meta-analysis by Steingrimsson et al (2020) evaluated 4 RCTs of adults with post-traumatic stress disorder (PTSD) treated with neurofeedback.17, Compared with sham neurofeedback, no treatment or other treatment, neurofeedback was associated with significant improvement in PTSD symptoms. Other primary outcomes were only reported in 1 trial each, and the authors concluded there was uncertainty regarding the ability of neurofeedback to improve PTSD symptoms, self-rated suicidality, executive cognitive functioning, and medication use. All studies were at moderate to high risk for bias, and were assessed as having some indirectness and imprecision.

Hong and Park (2022) conducted a meta-anlysis of 7 RCTs of adults with PTSD treated with neurofeedback.23, 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, of 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. Characteristics and results of the meta-analyses are summarized in Tables 22 through 24.

Table 22. Comparison of Studies Included in Systematic Review and Meta-analyses of Neurofeedback for PTSD

PTSD: post-traumatic stress disorder.

Table 23. Characteristics of Systematic Reviews and Meta-analyses of Neurofeedback for PTSD

EEG: electroencephalography; fMRI: functional magnetic resonance imaging; PTSD: post-traumatic stress disorder; RCT: randomized controlled trial.

Table 24. Results of Systematic Reviews and Meta-analyses of Neurofeedback for PTSD

CI: confidence interval; EEG: electroencephalography; fMRI: functional magnetic resonance imaging; NR: not reported; PTSD: post-traumatic stress disorder; SMD: standardized mean difference.

Other Disorders
Literature searches and a systematic review by Schoenberg et al (2014) assessing biofeedback for psychiatric and neurologic disorders24, have identified small studies (case reports, case series, comparative cohorts, small RCTs) of neurofeedback for the following conditions:

• Anxiety^24,
• Asperger syndrome^24,
• Autism spectrum disorder^25,26,
• Cigarette cravings^27,28,
• Chronic pain^29,
• Cognitive impairment^30,
• Depression^31,32,33,
• Depression, pain, or fatigue in patients with multiple sclerosis^34,
• Depression in alcohol addiction^24,
• Dissociative identity disorder^24,
• Fall risk^35,
• Fibromyalgia^36,37,
• Insomnia^38,
• Headache^39,40,
• Lower back pain^41,
• Multiple sclerosis^42,
• Overweight and obesity^43,44,
• Obsessive-compulsive disorder^45,46,
• Parkinson disease^47,48,49,
• Schizophrenia^50,51,24,52,
• Stroke^53,54,
• Tinnitus^55,
• Tourette syndrome^56,57,

Section Summary: Disorders Other Than Attention Deficit-Hyperactivity Disorder
The evidence for neurofeedback in individuals with disorders other than ADHD includes case reports, case series, comparative cohorts, small RCTs, and systematic reviews of these studies. For these disorders, the evidence is poor, and a number of questions regarding clinical efficacy remain unanswered. Larger RCTs that include either a sham or active control are needed to evaluate the effect of neurofeedback for these conditions.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Academy of Pediatrics
In 2019, the American Academy of Pediatrics (AAP) published a guideline update to the 2011 guideline for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents.58, The guideline states that electroencephalogram (EEG) biofeedback is one of several nonmedication treatments that have either too little evidence to support their recommendation for use or have little or no benefit.

The AAP Section on Integrative Medicine (2016), in a clinical report on mind-body therapies in children and youth, stated that research suggests benefits of peripheral forms of biofeedback, including EEG biofeedback (neurofeedback) in ADHD.59, The report noted no significant contraindications to the use of biofeedback, with the only barriers potentially being financial in nature. Of note, this clinical report has expired and is under review by the authorship team.

National Institute for Health and Care Excellence
In 2013, NICE issued guidance on management and support of children on the autism spectrum.60, The Institute stated that a number of treatments were considered but are not recommended, including neurofeedback.

Society for Developmental and Behavioral Pediatrics
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.61, 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."

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this review are listed in Table 25. The completion date for various registered trials of neurofeedback have passed without publication of results, suggesting the potential for publication bias.

Table 25. Summary of Key Trials   

NCT: national clinical trial.
^a Denotes industry-sponsored or cosponsored trial.

References

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Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

 This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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01/01/2024 NEW POLICY