Topic: Neurofeedback Date of Origin: July Section: Medicine Approved Date: January Policy No: 65 Effective Date: April 1, 2014

Transcription

1 Medical Policy Manual Topic: Neurofeedback Date of Origin: July 1998 Section: Medicine Approved Date: January 2014 Policy No: 65 Effective Date: April 1, 2014 IMPORTANT REMINDER Medical Policies are developed to provide guidance for members and providers regarding coverage in accordance with contract terms. Benefit determinations are based in all cases on the applicable contract language. To the extent there may be any conflict between the Medical Policy and contract language, the contract language takes precedence. PLEASE NOTE: Contracts exclude from coverage, among other things, services or procedures that are considered investigational or cosmetic. Providers may bill members for services or procedures that are considered investigational or cosmetic. Providers are encouraged to inform members before rendering such services that the members are likely to be financially responsible for the cost of these services. DESCRIPTION [1] Neurofeedback describes techniques of providing feedback about neuronal activity, as measured by electroencephalogram (EEG) or functional magnetic resonance imaging (fmri), in order to teach patients to self-regulate brain activity. Also known as EEG biofeedback, neurofeedback may utilize several techniques in an attempt to normalize unusual patterns of brain function. Neurofeedback may be conceptualized as a type of biofeedback that uses EEG as a source of feedback data. Although related in concept to biofeedback, neurofeedback differs in that the information fed back to the patient, i.e., EEG tracings, is not physiologic in nature. It is hypothesized that using the EEG as a measure of central nervous system (CNS) functioning can help train patients to modify or control their brain function in the treatment of a variety of disorders. MEDICAL POLICY CRITERIA The use of neurofeedback as a treatment for any disorder is considered investigational. SCIENTIFIC EVIDENCE [1] 1 - MED65

2 Behavioral (non-drug) treatments, including neurofeedback, result in both nonspecific and specific therapeutic effects. Nonspecific effects, sometimes called placebo effects, occur as a result of therapist contact, positive expectancies on the part of the patient and therapist, and other beneficial effects that occur as a result of being a patient in a therapeutic environment. Specific effects are those that occur only because of the active treatment, above any nonspecific effects that may be present. In order to isolate the independent contribution of neurofeedback on health outcomes (specific effects) and properly control for nonspecific treatment effects, well-designed clinical trials with the following attributes are necessary: Randomization Randomization helps to achieve equal distribution of individual differences by randomly assigning patients to either neurofeedback or sham treatment groups. This promotes the equal distribution of patient characteristics across the two study groups. Consequently, any observed differences in the outcome may, with reasonable assuredness, be attributed to the treatment under investigation. Sham control group A comparable sham control group helps control for placebo effects as well as for the variable natural history of the condition being treated. Blinding Blinding of study participants, caregivers, and investigators to the active or sham assignments helps control for bias for or against the treatment. Blinding assures that placebo effects do not get interpreted as true treatment effects. Large study population Small studies limit the ability to rule out chance as an explanation of study findings. Adequate follow-up Follow-up periods must be long enough to determine the durability of any treatment effects. The focus of the evidence review for neurofeedback for all indications is on randomized controlled trials (RCTs) with the attributes noted above. Literature Appraisal Relevant systematic reviews and key RCTs or controlled trials of neurofeedback are described below. Attention Deficit Hyperactivity Disorder (ADHD) Systematic Reviews and Meta-Analyses 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 neurofeedback for attention deficit/hyperactivity disorder (ADHD). [2] The authors concluded that neurofeedback 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 neurofeedback for ADHD was based on the need for further studies controlled for patient and therapist factors that could unduly influence outcomes. 2 - MED65

3 In 2009, Arns and colleagues published a meta-analysis on the effects of neurofeedback on the symptoms of hyperactivity, inattention, and impulsivity in children with a primary diagnosis of ADHD. [3] Fifteen studies met criteria (either between-subject or within-subject design) and were included in the analysis. Initial analysis indicated heterogeneity in study results, which typically would preclude meta-analysis. For this paper, studies were removed from the analysis until homogeneity was achieved. The adjusted analysis indicated similar effect sizes between neurofeedback and stimulant medication, and the authors concluded that neurofeedback could be considered efficacious and specific for ADHD. However, the analysis and conclusion were based on nonrandomized studies in which patients chose their treatment, which could increase potential selection bias. Four randomized controlled trials (RCTs) that utilized either a wait-list control or active control group were included in the meta-analysis. One of the studies is a German language report and another is an unpublished PhD thesis (total of 69 children); these have not been reviewed for this policy. The other 2 RCTs included in the systematic review are described below. [4,5] Overall, the literature included in this meta-analysis is characterized by small, poor quality studies with high potential for bias. The findings of the meta-analysis are also limited by significant heterogeneity in study results and exclusion of studies due to heterogeneity. In 2013, Vollebregt and colleagues conducted a systematic review and RCT to assess EEGneurofeedback treatment on neurocognitive function in children with ADHD. [6,7] Both the blinded RCT of 41 children (8-15 years) and the systematic review of additional studies found no significant treatment effect on neurocognitive functioning. Authors note this may be due to the limited sample size of available studies and other methodological limitations. Randomized Controlled Trials (RCT) The first of the RCTs mentioned above was a randomized study published in 2006 that examined brain activity following neurofeedback in 15 children with ADHD. [4] 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 randomly assigned to a nontreatment control condition. Functional magnetic resonance imaging revealed increased activation of the right anterior cingulate cortex, an area related to selective attention that previously was 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. In the second RCT in the meta-analysis, to control for nonspecific effects (attention training) and confounding variables (parental engagement), Gevensleben and colleagues compared neurofeedback with a control intervention of participants in a computerized attention skills training. [5] All children were drug-naïve or drug-free without concurring psychotherapy for at least 6 weeks before starting training. The 2 training conditions were designed to be as similar as possible, using computer games, positive reinforcement by a trainer, homework, and parental encouragement in using the skills/strategies learned during training in real-life situations. Both groups participated in 2 blocks of 9 sessions (approximately 100 minutes per session plus a break), with 2 3 sessions per week, and parents were informed that both treatments were expected to be beneficial but were not informed as to which type of training their child had been assigned. A total of 102 children were randomly assigned in a 3:2 ratio; 8 children were excluded due to need for medical treatment or noncompliance with the study protocol by either the children or their parents, resulting in 59 children in neurofeedback and 35 in attention training (92% follow-up). Slow cortical potentials (SCPs) and theta/beta training were compared by starting with 1 type of training in the first block and then the 3 - MED65

4 other (counterbalanced order) in the second block. Investigator evaluations were performed by the teachers, and thus, the teachers were not blinded to the treatment. At the end of training/testing, there were no significant differences in parents attitude toward the 2 training conditions or in the perceived motivation of their children. Approximately 40% of the parents either did not know which training their child had participated in or guessed the wrong group. Both parents and teachers rated the neurofeedback group as more improved on the hyperactivity subcomponent of a Strength and Disabilities Questionnaire (e.g., SDQ, 19% vs. 3%, respectively, improved) and on a German ADHD scale (e.g., 26% vs. 9%, respectively, improved). Thirty children in the neurofeedback group (52%) and 10 children in the attention training group (29%) improved more than 25% in the German ADHD scale (odds ratio: 2.68), which was the primary outcome measure. Other components of the SDQ, including emotional symptoms, conduct problems, peer problems, and prosocial behavior, were not different between the 2 training conditions. No significant differences were noted between the 2 neurofeedback training protocols. Results of this randomized controlled study suggested that neurofeedback may have specific effects on attention and hyperactivity beyond those achieved by attention training and parental involvement. The authors concluded that future studies should further address the specificity of effects and how to optimize the benefit of neurofeedback as a treatment module for ADHD. Six-month follow-up from the Gevensleben et al RCT [5] described above was reported in [8] Of the 94 children who completed treatment, 17 started medication during the follow-up interval, and parents of 16 children did not return the questionnaires. Follow-up was obtained in 61 children (65%) of the original per-protocol 102 children. Although the percentage of dropouts did not differ between the 2 groups, dropouts tended to have higher scores on the German ADHD rating scale (FBB-HKS), particularly in the control group. The difference in dropouts between the groups limits the interpretation of the comparative data, as the scores in the 2 groups included in follow-up were not similar at baseline (e.g., baseline FBB-HKS of 1.50 for the neurofeedback group and 1.37 for the control group). The improvement observed in the neurofeedback group after treatment appeared to be preserved at 6-month follow-up. For example, the inattention subscore of the FBB-HKS improved from 2.02 to 1.51 after treatment and remained at 1.49 at 6-month follow-up (moderate effect size of 0.73). The hyperactivity/impulsivity subscore improved from 1.10 to 0.79 after treatment and remained at 0.76 at 6-month follow-up (small effect size of 0.35). The authors of this European study noted that the treatment effects appear to be limited but considered neurofeedback to be potentially effective as one component of a multimodal treatment approach. Meisel and colleagues conducted a small study (n=23) comparing neurofeedback to pharmacological treatment in children (7-14 years, 11 boys, 12 girls) with ADHD. [9] Patients either underwent 40 theta/beta sessions or received methylphenidate. Behavioral rating scores were gathered at baseline, post-treatment, two and six months follow-up. Behavioral rating scale questionnaires were completed by parents and teachers. No differences between groups were observed in ADHD functional impairment or primary symptoms. Authors did report a significant improvement in academic performance in the neurofeedback group over medication group; however, these results should be interpreted with caution due to considerable methodological limitations of this study. It is not clear the study sample size was sufficient enough to detect true differences between treatment groups. In addition, treatment effects were evaluated by teachers and parents, which may have introduced additional bias in the assessment of ADHD symptoms and functional impairment. Three additional small RCTs found no significant difference between neurofeedback and either attention skills training, placebo training, or biofeedback relaxation training. [10-12] Comparison with 4 - MED65

5 biofeedback relaxation training suggested that non-specific factors such as a structured learning environment may contribute to the effects of neurofeedback. [11] Nonrandomized Comparative Studies Two studies were identified, comparing neurofeedback and methylphenidate (stimulant) therapy in patients with attention deficit disorder. [13,14] In these nonrandomized studies, patients in both groups reported improvements in various measures of attention; however, nonrandomized studies limit the ability to reach scientific conclusions concerning the efficacy of neurofeedback in the treatment of AD/HD due to the lack of design attributes described above. Summary There are a few small RCTs of neurofeedback for the treatment of ADHD, and systematic reviews of these studies have also been conducted. The available studies have methodologic limitations, such as small sample size, and the results are not consistent in showing improvements in health outcomes. One difficulty with this area of research is isolating the effect of neurofeedback from non-specific effects of a trial. Studies that attempted to use active controls 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. Autism Spectrum Disorder (ASD) Systematic Reviews In 2013 Frye and colleagues conducted a systematic review on the treatment of seizures in patients with autism spectrum disorder. [15] Studies were selected systematically from major electronic databases and then reviewed by a panel of ASD treatment experts. Authors concluded there was limited evidence to support the use of neurofeedback in patients with seizures associated with ASD. In a 2009 single-author systematic review of novel and emerging treatments for ASD, neurofeedback received a grade C recommendation (Grade C recommendation: supported by 1 nonrandomized controlled trial). [16] The author reviewed literature in the PubMed and Google Scholar databases for clinical trial reports on numerous biological (e.g., nutritional supplements, special diets, medications) and nonbiological (e.g., neurofeedback, massage) treatments. Due to the extensive amount of literature, a critical analysis of the quality of the studies was not included. The study referenced for neurofeedback was a nonrandomized pilot study that included 12 children with ASD who received neurofeedback and an untreated control group of 12 children who were matched by sex, age, and disorder severity. [17] The study found a greater reduction in ASD symptoms based on the Autism Treatment Evaluation Checklists (A TEC) and parental assessments in the group treated with neurofeedback compared with the control group. While this trial is useful in informing hypothesis formation, it does not permit conclusions on efficacy due to the lack of randomized treatment allocation, small patient population, lack of a sham control group, and short-term followup period. Randomized sham controlled trials in larger numbers of patients are required to validate these findings due to the possibility of nonspecific effects (e.g., attention training) and confounding variables (e.g., parental engagement and expectation). 5 - MED65

6 No randomized sham controlled trials on neurofeedback for ASD have been identified. Cognitive Performance One small (n=6) quasi-randomized, double-blind pilot study was identified that examined whether increasing peak alpha frequency would improve cognitive performance in older adults (70 78 years of age). [18] 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. Epilepsy A 2009 meta-analysis by Tan and colleagues identified 63 studies on neurofeedback for treatment of epilepsy. [19] Ten of the 63 studies met inclusion criteria; 9 of these studies included fewer than 10 subjects. The studies were published between 1974 and 2001 and utilized a pre-post design in patients with epilepsy refractory to medical treatment; only one controlled study was included. The metaanalysis showed a small effect size for treatment (-0.233), with a likelihood of publication bias based on funnel plot. Randomized placebo-controlled trials are needed to evaluate the effect of neurofeedback on seizure frequency in patients with epilepsy. Fibromyalgia In 2010, Kayiran and colleagues reported a randomized single blind study of neurofeedback versus escitalopram in 40 patients with fibromyalgia. [20] Patients in the neurofeedback group were instructed to widen a river on a computer monitor which corresponded to increasing sensory motor activity and decreasing theta activity. Patients received 5 sessions per week for 4 weeks. The control group received escitalopram for 8 weeks. Outcome measures at baseline and at weeks 2, 4, 8, 16, and 24 included visual analog scale (VAS) for pain, Hamilton and Beck Depression and Anxiety Inventory Scales, Fibromyalgia Impact Questionnaire and Short Form-36. Mean amplitudes of electroencephalogram (EEG) rhythms and the theta/sensory motor rhythms were also measured in the neurofeedback group. At baseline, the control group scored higher on the Hamilton and Beck Anxiety Scales and the Hamilton Depression Scale; all other baseline measures were similar between groups. Both groups showed improvements over time, with significantly better results in the neurofeedback group. There were no changes over time in mean amplitudes of EEG rhythms and essentially no change in the theta/sensory motor rhythm ratio (reduced only at week 4). This study is limited by the difference in intensity of treatment and contact with investigators between the neurofeedback and escitalopram groups. As previously noted, sham controlled trials are needed when assessing the effect of neurofeedback on subjective outcome measures. Migraine Headaches Walker reported quantitative EEG (QEEG) for the treatment of migraine headaches in a RCT of 46 patients. [21] Results were compared with 25 patients who chose not to do neurofeedback and continued anti-migraine drug therapy. Since baseline QEEG assessment in 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 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 6 - MED65

7 majority of patients in the QEEG group but not the drug therapy group. Fifty-four percent of the QEEG group 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%. Limitations of this study include the patient self-report of headache status through diary logs which may not be the most reliable measure of symptom improvement. Randomized sham-controlled trials are needed to adequately evaluate this treatment approach. Obsessive-Compulsive Disorder (OCD) In 2013, Koprivova et al. reported a double-blind randomized sham-controlled trial of independent component neurofeedback in 20 patients with obsessive-compulsive disorder. [22] Independent component neurofeedback is based on the individual diagnosis of pathological EEG sources and was directed at down-training 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. Larger, long-term RCTs are needed in order to assess the efficacy of neurofeedback treatment on patients with OCD. Primary Insomnia In 2010, Cortoos et al. published a small (n=17) RCT on the effect of neurofeedback training or biofeedback training (placebo control) on objective and subjective sleep in patients with primary insomnia. [23] Of 158 subjects with sleep complaints who were interested in participating, 131 (89%) were excluded due to study criteria or unwillingness to remain medication free during the study period. Following polysomnograph (PSG) recorded sleep in the laboratory, all subjects received 20 sessions of therapist-controlled telefeedback training at home over a period of 8 weeks. The neurofeedback group was trained to increase the sensory-motor rhythm (12-15 Hz) and inhibit theta power (4-8 Hz) and high beta power (20-30 Hz). The biofeedback group was trained to decrease electromyographic (EMG) activity, which was equated with the reinforcement of relaxation (placebo control). Both treatments reduced sleep latency by 40% to 45% (22 minutes at baseline) on post-treatment PSG, measured 2 weeks after the end of training. Neurofeedback training reduced wake after sleep onset (54% vs. 13% decrease, respectively; however, no interaction was found on the two-way ANOVA) and increased total sleep time (40 minutes vs. less than 5 minutes, respectively, p<0.05). This study is limited by the small number of subjects, differences in sleep parameters at baseline, and short follow-up. Additional studies are needed to evaluate this novel treatment approach. Substance Abuse A 2008 systematic review of neurofeedback as a treatment for substance abuse disorders described difficulties in assessing the efficacy of this and other substance abuse treatments, including the lack of clearly established outcome measures, differing effects of the various drugs, presence of comorbid conditions, absence of a gold standard treatment, and use as an add-on to other behavioral treatment regimens. [24] The authors 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. The authors also noted that few large-scale studies of neurofeedback in addictive disorders have been 7 - MED65

8 reported, and a shortcoming of the evidence for alpha-theta training is that it has not been shown to be superior to sham treatment. Tourette Syndrome In 2011, the working group of the European Society for the Study of Tourette Syndrome conducted a systematic review of behavioral and psychosocial interventions for Tourette syndrome and other tic disorders. [25] There were no randomized or comparative trials on neurofeedback for Tourette syndrome; the literature was limited to 2 case series. Since the systematic review, no RCTs for neurofeedback for this indication have been published. Other Conditions Interest has been noted in the use of neurofeedback for the treatment of the following conditions: Anxiety and panic disorders Depression Menopausal symptoms Parkinson s Disease Posttraumatic stress disorder (PTSD) Stress management and relaxation Traumatic brain injury (TBI) There are currently no RCTs, comparative trials, or systematic reviews published for these indications. Clinical Practice Guidelines and Position Statements There are currently no evidence-based clinical practice guidelines or position statements from U.S. professional societies that recommend the use of neurofeedback for any indication. American Academy of Pediatrics (AAP) The AAP s 2011 clinical practice guidelines on the diagnosis and treatment of ADHD did not include neurofeedback in the treatment recommendations. [26] EEG biofeedback was included on the list of areas for future research. The AAP guidelines for adolescent depression and for closed head injury do not address neurofeedback. [27] In a 2013 statement on Neurofeedback, Hypnotherapy, and Guided Imagery, the AAP indicated that, The studies on the use of neurofeedback to date have been criticized for lacking the appropriate controls or the random assignment of test subjects to the treatment or sham treatment groups. It should also be pointed out that neurofeedback treatment is an expensive approach to treating ADHD. [28] American Psychiatric Association (APA) While the 2004 APA practice guideline for treatment of patient with acute or posttraumatic stress disorder [29] was silent on neurofeedback, the 2009 updated review noted that the utility and 8 - MED65

9 generalizability of conclusions from [current] studies are limited by methodological issues such as lack of formalized diagnostic procedures, inclusion of non-ptsd patients, very high dropout rates, unspecified handling of dropouts or missing data, and lack of blinding of assessors. [30] Neurofeedback was not included in APA practice guidelines on treatment of substance abuse [31], major depression [32], obsessive-compulsive disorder (OCD) [33] or panic disorder [34]. American Academy of Child and Adolescent Psychiatry (AACAP) [35] The current AACAP practice parameters do not include neurofeedback in the treatment recommendations for any psychiatric condition. International Society for Neurofeedback & Research (ISNR) [36,37] The ISNR 2012 guideline is related to standards for practice but does not address specific treatments, indications, or scientific evidence. Summary The scientific evidence does not permit conclusions concerning the effect of neurofeedback on health outcomes for any condition. A number of questions regarding clinical efficacy remain to be answered before applying neurofeedback techniques to patients with attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), cognitive performance, epilepsy, fibromyalgia, insomnia, migraine headache, obsessive-compulsive disorder, substance abuse disorder or Tourette syndrome,. In addition, there are no evidence-based clincial practice guidelines or clinical position statements from U.S. professional societies that recommend the use of neurofeedback for any condition. Therefore, neurofeedback is considered investigational for all indications. REFERENCES 1. BlueCross BlueShield Association Medical Policy Reference Manual "Neurofeedback." Policy No Monastra, VJ, Lynn, S, Linden, M, Lubar, JF, Gruzelier, J, LaVaque, TJ. Electroencephalographic biofeedback in the treatment of attention-deficit/hyperactivity disorder. Appl Psychophysiol Biofeedback Jun;30(2): PMID: Arns, M, de Ridder, S, Strehl, U, Breteler, M, Coenen, A. Efficacy of neurofeedback treatment in ADHD: the effects on inattention, impulsivity and hyperactivity: a meta-analysis. Clin EEG Neurosci Jul;40(3): PMID: Levesque, J, Beauregard, M, Mensour, B. Effect of neurofeedback training on the neural substrates of selective attention in children with attention-deficit/hyperactivity disorder: a functional magnetic resonance imaging study. Neurosci Lett Feb 20;394(3): PMID: Gevensleben, H, Holl, B, Albrecht, B, et al. Is neurofeedback an efficacious treatment for ADHD? A randomised controlled clinical trial. J Child Psychol Psychiatry Jul;50(7): PMID: Vollebregt, MA, van Dongen-Boomsma, M, Buitelaar, JK, Slaats-Willemse, D. Does EEGneurofeedback improve neurocognitive functioning in children with attentiondeficit/hyperactivity disorder? A systematic review and a double-blind placebo-controlled study. J Child Psychol Psychiatry Oct 30. PMID: MED65

10 7. van Dongen-Boomsma, M, Vollebregt, MA, Slaats-Willemse, D, Buitelaar, JK. A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder. J Clin Psychiatry Aug;74(8): PMID: 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 Sep;19(9): PMID: Meisel, V, Servera, M, Garcia-Banda, G, Cardo, E, Moreno, I. Neurofeedback and standard pharmacological intervention in ADHD: a randomized controlled trial with six-month follow-up. Biological psychology Sep;94(1): PMID: Gevensleben, H, Rothenberger, A, Moll, GH, Heinrich, H. Neurofeedback in children with ADHD: validation and challenges. Expert review of neurotherapeutics Apr;12(4): PMID: Bakhshayesh, AR, Hansch, S, Wyschkon, A, Rezai, MJ, Esser, G. Neurofeedback in ADHD: a single-blind randomized controlled trial. Eur Child Adolesc Psychiatry Sep;20(9): PMID: Duric, NS, Assmus, J, Gundersen, D, Elgen, IB. Neurofeedback for the treatment of children and adolescents with ADHD: a randomized and controlled clinical trial using parental reports. BMC psychiatry. 2012;12:107. PMID: Fuchs, T, Birbaumer, N, Lutzenberger, W, Gruzelier, JH, Kaiser, J. Neurofeedback treatment for attention-deficit/hyperactivity disorder in children: a comparison with methylphenidate. Appl Psychophysiol Biofeedback Mar;28(1):1-12. PMID: Rossiter, T. The effectiveness of neurofeedback and stimulant drugs in treating AD/HD: part II. Replication. Appl Psychophysiol Biofeedback Dec;29(4): PMID: Frye, RE, Rossignol, D, Casanova, MF, et al. A Review of Traditional and Novel Treatments for Seizures in Autism Spectrum Disorder: Findings from a Systematic Review and Expert Panel. Frontiers in public health. 2013;1:31. PMID: Rossignol, DA. Novel and emerging treatments for autism spectrum disorders: a systematic review. Ann Clin Psychiatry Oct-Dec;21(4): PMID: Jarusiewicz, B. Efficacy of neurofeedback for children in the autism spectrum: a pilot study. J Neurotherapy. 2002;6(4): PMID: No PMID Entry 18. Angelakis, E, Stathopoulou, S, Frymiare, JL, Green, DL, Lubar, JF, Kounios, J. EEG neurofeedback: a brief overview and an example of peak alpha frequency training for cognitive enhancement in the elderly. Clin Neuropsychol Jan;21(1): PMID: Tan, G, Thornby, J, Hammond, DC, et al. Meta-analysis of EEG biofeedback in treating epilepsy. Clin EEG Neurosci Jul;40(3): PMID: Kayiran, S, Dursun, E, Dursun, N, Ermutlu, N, Karamursel, S. Neurofeedback intervention in fibromyalgia syndrome; a randomized, controlled, rater blind clinical trial. Appl Psychophysiol Biofeedback Dec;35(4): PMID: Walker, JE. QEEG-guided neurofeedback for recurrent migraine headaches. Clin EEG Neurosci Jan;42(1): PMID: Koprivova, J, Congedo, M, Raszka, M, Prasko, J, Brunovsky, M, Horacek, J. Prediction of treatment response and the effect of independent component neurofeedback in obsessivecompulsive disorder: a randomized, sham-controlled, double-blind study. Neuropsychobiology. 2013;67(4): PMID: Cortoos, A, De Valck, E, Arns, M, Breteler, MH, Cluydts, R. An exploratory study on the effects of tele-neurofeedback and tele-biofeedback on objective and subjective sleep in patients with primary insomnia. Appl Psychophysiol Biofeedback Jun;35(2): PMID: MED65

11 24. 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 Mar;33(1):1-28. PMID: Verdellen, C, van de Griendt, J, Hartmann, A, Murphy, T. European clinical guidelines for Tourette syndrome and other tic disorders. Part III: behavioural and psychosocial interventions. Eur Child Adolesc Psychiatry Apr;20(4): PMID: Wolraich, M, Brown, L, Brown, RT, et al. ADHD: clinical practice guideline for the diagnosis, evaluation, and treatment of attention-deficit/hyperactivity disorder in children and adolescents. Pediatrics Nov;128(5): PMID: Cheung, AH, Zuckerbrot, RA, Jensen, PS, Ghalib, K, Laraque, D, Stein, RE. Guidelines for Adolescent Depression in Primary Care (GLAD-PC): II. Treatment and ongoing management. Pediatrics Nov;120(5):e PMID: American Academy of Pediatrics healthchildren.org website. Health Issues, Conditions, ADHD: Neurofeedback, Hypnotherapy, and Guided Imagery. [cited 12/27/2013]; Available from: Guided-Imagery-and-Biofeedback.aspx 29. Ursano, RJ, Bell, C, Eth, S, et al. Practice guideline for the treatment of patients with acute stress disorder and posttraumatic stress disorder. Am J Psychiatry Nov;161(11 Suppl):3-31. PMID: Benedek DM, Friedman MJ, Zatzick D, Ursano RF. Guideline Watch (March 2009): Practice Guideline for the Treatment of Patients With Acute Stress Disorder and Posttraumatic Stress Disorder. [cited 12/27/2013]; Available from: Kleber, HD, Weiss, RD, Anton, RF, et al. Treatment of patients with substance use disorders, second edition. American Psychiatic Association. Am J Psychiatry Aug;163(8 Suppl):5-82. PMID: Rosenbaum JF, Thase ME, Trivedi MH, et al. Practice Guideline for the Treatment of Patients With Panic Disorder, Second Edition. American Psychiatric Association. [cited 12/27/2013]; Available from: APA Practice Guidelines. Guideline Watch (March 2013): Practice Guideline for the Treatment of Patients with Obsessive-Compulsive Disorder. [cited 12/27/2013]; Available from: Murray B. Stein, Goin MK, Pollack MH, et al. Practice Guideline for the Treatment of Patients With Panic Disorder, Second Edition. American Psychiatric Association. [cited 12/27/2013]; Available from: American Academy of Child & Adolescent Psychiatry (AACAP) website. Practice Parameters and Resource Centers.. [cited 12/27/2013]; Available from: e_centers/practice_parameters.aspx 36. International society for Neurofeedback and Research (ISNR). Practice Guidelines for Neurofeedback. [cited 12/27/2013]; Available from: International Society for Neurofeedback and Research (ISNR). Code of Ethical Principles and Professional Conduct. [cited 12/27/2013]; Available from: CROSS REFERENCES 11 - MED65

12 Biofeedback, Allied Health, Policy No. 32 CODES NUMBER DESCRIPTION CPT Individual psychophysiological therapy incorporating biofeedback training by any modality (face-to-face with the patient), with psychotherapy (eg, insight oriented, behavior modifying or supportive psychotherapy); approximately minutes minutes Biofeedback training by any modality HCPCS No code 12 - MED65