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Research – Neuro-feedback therapy for ADHD

Is neuro feedback effective for treating people (13yo, pubescence age range) with ASD (level 2)? (update to 2019 research)

Is neuro feedback effective for treating people (13yo, pubescence age range) with ASD (level 2) and ADHD?

Is neuro feedback effective for treating people (13yo, pubescence age range) with ADHD? Brief Is it suitable for prolonged/ongoing treatment and in conjunction with other allied health treatments?

What are some side effects of neuro feedback treatment? i.e. increase in tics

Is there evidence in the published literature that neuro feedback therapy can effectively treat “paroxysmal activity on executive functioning, reduce anxiety, improve emotional self-regulation and language processing issues.”

Date 09/04/2021

Requester(s) Julie s47F - personal priv - Senior Technical Advisor (TAB)

Researcher Jane s47F - personal priv (Research Team Leader - TAB)

Cleared N/A

Please note:

The research and literature reviews collated by our TAB Research Team are not to be shared external to the Branch. These are for internal TAB use only and are intended to assist our advisors with their reasonable and necessary decision-making.

Delegates have access to a wide variety of comprehensive guidance material. If Delegates require further information on access or planning matters they are to call the TAPS line for advice.

The Research Team are unable to ensure that the information listed below provides an accurate & up-to-date snapshot of these matters.

1 Contents

2 Summary ……………………………………………………………………………………………………………………….. 2

3 What is neurofeedback therapy?………………………………………………………………………………………. 2

4 Neurofeedback in the treatment of autism spectrum disorder …………………………………………….. 4

5 Neurofeedback in the treatment of attention deficit hyperactivity disorder ………………………….. 9

6 References …………………………………………………………………………………………………………………… 15

Research – Neurofeedback therapy for children and adolescents with ASD or ADHD

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2 Summary

Neurofeedback therapy for the treatment of ASD is not considered an evidence based practice. The few randomised controlled trials that do exist are of poor quality. Further large scale, high quality studies that include best practice treatments as a comparison group are required.
Most commonly, studies include “high functioning” children with ASD and do not provide severity level. Therefore, results can only be generalised to that population group.
Comorbid ADHD is not reliably assessed in current studies, possibly owing to the current exclusion criteria in the classification system that rule out coexisting ASD and ADHD. Few neurofeedback studies have focused on ADHD in individuals with ASD.
Multiple meta-analyses have investigated the effectiveness of neurofeedback therapy for ADHD. They have found that neurofeedback is superior to ‘non-active’ control groups for reducing inattention and hyperactivity/impulsivity symptoms when parents provide self-reported assessments. When less biased examiners (teachers) perform assessments the results are more commonly non-significant a. Further high quality studies (better blinding, use of objective measures) comparing to current best practice treatment for ADHD are required b. Some authors have suggested that neurofeedback be used as a complimentary/combined treatment with stimulants c. Neurofeedback does not appear in any ADHD clinical practice guidelines or treatment recommendations
No studies could be located which used neurofeedback therapy in conjunction with other allied health treatments
Given that neurofeedback therapy is a non-invasive treatment, adverse events are unlikely. One study did look investigate this and reported no significant adverse effects or sleep problems after neurofeedback therapy [1]. a. No evidence of an increase in tics following neurofeedback therapy
No consensus on protocol, intensity or duration of treatment
There is no evidence that neurofeedback therapy can effectively treat “paroxysmal activity on executive functioning, reduce anxiety, improve emotional self-regulation and language processing issues.” a. There is only weak evidence of its effectiveness in reducing inattention and hyperactivity/impulsivity symptoms in those with ADHD

3 What is neurofeedback therapy?

Research – Neurofeedback therapy for children and adolescents with ASD or ADHD

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Neurofeedback is a kind of biofeedback, which utilises operant conditioning to teach self-

control of brain functions to subjects by measuring brain waves through

electroencephalography (EEG) or functional magnetic resonance imaging (fMRI) and

providing a feedback signal [2, 3]. Positive or negative feedback is produced for desirable or

undesirable brain activities, respectively. Various EEG components are extracted and fed to

subjects using online feedback loop in the form of audio, video or their combination.

Accordingly, electrophysiological components are separately demonstrated [2]. As an

illustration, the power of a signal in a frequency band can be shown by a varying bar graph.

During this procedure, the subject becomes aware of the changes occurring during training

and will be able to assess his/her progress in order to achieve optimum performance.

Neurofeedback treatment protocols mainly focus on the alpha, beta, delta, theta, and

gamma treatment or a combination of them such as alpha/theta ratio, beta/theta ratio, etc.

[2]. Table 1 below provides an overview of common brainwaves, frequencies and

characteristics.

Table 2. Specific brainwaves with their characteristics

Common Frequency brainwave General characteristics range (Hz) frequency

Sleep, repair, complex problem solving, unawareness, deep- Delta 1–4 unconsciousness

Creativity, insight, deep states, unconsciousness, optimal Theta 4–8 meditative state, depression, anxiety, distractibility

Alpha 8–13 Alertness and peacefulness, readiness, meditation, deeply-relaxed

Lower alpha 8–10 Recalling

Research – Neurofeedback therapy for children and adolescents with ASD or ADHD

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Table 2. Specific brainwaves with their characteristics

Common Frequency brainwave General characteristics range (Hz) frequency

Upper alpha 10–13 Optimize cognitive performance

SMR

(sensorimotor 13–15 Mental alertness, physical relaxation

rhythm)

Thinking, focusing, sustained attention, tension, alertness, Beta 15–20 excitement

High beta 20–32 Intensity, hyper alertness, anxiety

32–100 or Learning, cognitive processing, problem solving tasks, mental Gamma 40 sharpness, brain activity, organize the brain

4 Neurofeedback in the treatment of autism spectrum disorder

There are very few high quality studies that investigate the use of neurofeedback therapy for children and adolescents with ASD (Table 2). A recent systematic review found that 19/20 studies which investigated neurofeedback therapy obtained positive results [3]. However, they provided not critical analysis of the included studies.

The limitations of the studies include:

Small sample sizes (ranging from n = 10 to 28) meaning results should be interpreted with caution
Lack of criterion standard diagnostic instruments
No clear guidance as to how many sessions of neurofeedback are needed for optimal results (ranged from 5 to 69 sessions)

Research – Neurofeedback therapy for children and adolescents with ASD or ADHD

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No firm agreement on optimal treatment protocols
Studies restricted to individuals with ASD with an IQ above 70 (‘high-functioning ASD’); this selection bias does not allow for the generalization of current findings
Insufficient control interventions - no studies compared to best practice treatments

A further systematic review concluded that existing evidence does not support neurofeedback as a treatment that can be recommended for ASD core symptoms [4]. They also suggest that studies with outcomes in favour of neurofeedback might be showing an improvement in comorbid ADHD symptoms rather than a true improvement in core ASD symptoms.

Research – Neurofeedback therapy for children and adolescents with ASD or ADHD

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Table 2. Literature Review - ASD

Author Aim/Objective Methods Results .. Is neurofeedback : . 20 studies (n = 443) met the inclusion van Hoogdalem, Feijs . Systematic Review — : [3] (NF) an effective criteria (3 RCT, 13 non-randomised & 4 alternative Methods designed in experimental). treatment in children accordance with Preferred with ASD? Reporting Items for Systematic Selected studies were heterogeneous Reviews and Meta-Analyses in their design and methodology. The (PRISMA) statement NF therapy protocol as well as the duration, frequency, and number of Eligibility criteria sessions varied between studies. e NF asa treatment for ASD in children (<18 years) Results qualitatively presented.

e Diagnosis for autism had to be diagnosed by DSM-III-R, 19/20 studies found some form of

DSM-IV, or DSM-5 positive result. Various studies also guidelines reported that specific functions Peer reviewed improved while other functions did Experimental in design with _ not, or even became worse. a control group Socialisation appears to improve most consistently. Excluded e Adults Long term effects

Research — Neurofeedback therapy for children and adolescents with ASD or ADHD

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Level & Quality of evidence

MODERATE

Lacked quality assessment of included studies. The authors take positive findings at face value and don’t criticise further. 3/4 of the included RCTs are not blinded and all have small samples.

Sample sizes of all included studies were quite small (ranging from n=10 ton= 28) meaning results should be interpreted with caution.

Lack of qualitatively good

studies, which makes it hard to draw strong conclusions

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Table 2. Literature Review - ASD

Author Aim/Objective

Holtmann, Steiner To review current

[4] studies on the effectiveness of neurofeedback as a method of treatment of the core symptoms of ASD.

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Methods

e Other disorders such as ADHD, learning disorders, intellectual disability

e Case studies and book chapters

No quality assessment of included studies.

Literature review

Other than listing the databases searched there are no descriptions on the eligibility criteria, data collection or quality assessment methods used.

Authors state that ‘all available data on neurofeedback in ASD and in comorbid ASD / ADHD are reviewed’. This cannot be determined without a search strategy or methods.

Research — Neurofeedback therapy for children and adolescents with ASD or ADHD

Results

2 RCTs looked at longitudinal effects. One found significant maintenance in social behaviour and executive function at 12 months. The other study showed that NF did not significantly reduced ASD symptoms.

Non-invasive, no side effects

Qualitative interpretation of individual studies provided along with corresponding percentage changes/descriptive statistics.

Studies with outcomes in favour of neurofeedback might be showing an improvement in comorbid ADHD symptoms rather than a true improvement in core ASD symptoms.

Lack of blinding in controlled studies, therefore effects might be biased by rater expectations (i.e. parents).

Authors find that existing evidence does not support neurofeedback as a

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Level & Quality of evidence

No clear guidance as to how many sessions of NF are needed for optimal results (ranged from 5 to 69 sessions).

No firm agreement on optimal treatment protocols.

LOW

e Studies don’t use criterion standard diagnostic instruments

e Neurofeedback should be compared with best practice ASD interventions in order to determine its efficacy and effectiveness

e Unknown whether neurofeedback adds therapeutic value to existing methods

e Studies restricted to individuals with ASD with

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Table 2. Literature Review - ASD

Level & Quality of

Author Aim/Objective Methods Results . evidence

treatment that can be recommended an IQ above 70 (‘high-

for ASD core symptoms. functioning ASD’); this selection bias does not allow for the generalization of current findings

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5 Neurofeedback in the treatment of attention deficit hyperactivity disorder

The delivery of neurofeedback therapy for children and adolescents with ADHD has been researched extensively over the past two decades (Table 3). Evidence from meta-analyses of RCTs show that most studies compare neurofeedback to a ‘non-active’ control group (described as control group conditions without enough proven efficacy to reduce ADHD symptoms – such as sham neurofeedback, wait list, electromyographic biofeedback, and physical activity) and not to current best practice such as stimulants/medication.

• The majority of meta-analyses (in the <18 year old cohort) find that neurofeedback is superior to ‘non-active’ control groups for reducing inattention and hyperactivity/impulsivity symptoms [5-7].

However, the above finding needs to be interpreted in relation to the below limitations

Pre-post-test comparisons are calculated using measures performed by proximal evaluators (often parents). When ‘possibly blind’ evaluations are used (usually teachers) the magnitude of positive effect is often much smaller or non-significant. There is less bias when using a teachers subjective assessment rather than parent report
This substantial variation in results depending on who provides the evaluation means conclusions about the effectiveness of neurofeedback therapy are fragile/weak
The magnitude of effect sizes that support the efficacy of neurofeedback at present are small (<0.5)

Neurofeedback compared to stimulants shows that stimulants are more effective, even when parents are used to make the evaluations [7, 8].

Although current evidence on neurofeedback for ADHD is considered weak positive, it is suggested that neurofeedback be used as a complimentary/combined treatment with stimulants.

At this stage, neurofeedback does not appear in any ADHD clinical practice guidelines or treatment recommendations in the USA, Canada, UK or Spain (Aus guidelines currently being developed).

Research – Neurofeedback therapy for children and adolescents with ASD or ADHD

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Table 3. Literature Review - ADHD

Author Aim/Objective

Summarise and review the results of previous meta-analyses and present the results of a new meta-analysis of randomized controlled ADHD neurofeedback trials.

Riesco-Matias, Yela-Bernabe [7]

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Methods

Meta-analysis

Inclusion criteria

Meta-analytic methodology used to summarize the effect of studies

RCTs published in peer- reviewed journals

Sample: primary ADHD diagnosis (DSM or ICD)

Mean age < 18 years old standard EEG-NF theta/beta ratio training, standard SCP or SMR, and theta training; Validated scale pre—post treatment measurements of at least one of the core ADHD symptoms (inattention, hyperactivity, impulsivity, hyperactivity-impulsivity)

Research — Neurofeedback therapy for children and adolescents with ASD or ADHD

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Results

7 meta-analyses were reviewed and 17 studies were incorporated into the

new meta-analysis.

All meta-analyses that calculated the effects of neurofeedback applied to

inattention symptoms and/or

hyperactivity-impulsivity symptoms

versus the effect of non-active control condition groups and used most-

proximal evaluator data (often

parents) obtained significant effect sizes in favour of neurofeedback.

No meta-analysis has found effective

neurofeedback treatment for

hyperactivity-impulsivity symptoms when possibly blind ratings (often teacher ratings) have been used. Only one meta- analysis was in favour of

Level & Quality of evidence

HIGH

There is less bias when using a teacher’s subjective assessment rather than parent report. Therefore, this substantial variation in results depending on who provides the evaluation means conclusions are ‘fragile’.

Current evidence on neurofeedback for ADHD is considered weak

positive.

New RCTs that establish links between ADHD symptom measurements,

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Table 3. Literature Review - ADHD

Author Aim/Objective

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Methods

Exclusion criteria

e <5 participants per group

e Language other than English or Spanish

e Sample was shared with another study included in the current meta-analysis

e Insufficient data to calculate target effect sizes

e No inclusion criteria

Research — Neurofeedback therapy for children and adolescents with ASD or ADHD

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Results

neurofeedback for inattention symptoms

Results of the updated meta-analysis are in support of previous findings, i.e. results are only effective when parents are providing ratings of change/effectiveness, and these effects are small (<0.5)

NFvcontrol group for inattention using most proximal evaluator: ES -0.33, 95% Cl -0.56, -0.10
NFvcontrol group inattention using probably

blind evaluator: ES -0.25, 95%

Cl -0.45, -0.04

NFvcontrol for hyperactivity/impulsivity symptoms using most proximal evaluator: ES -0.17, 95% Cl -0.33, -0.02

Level & Quality of evidence

subjects’ learning after neurofeedback, and neurophysiological measures could improve the quality of the current conclusions.

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Table 3. Literature Review - ADHD

Author

Bussalb, Congedo [5]

Aim/Objective

To update the meta- analysis performed by Cortese, Ferrin [6] and evaluate the efficacy of neurofeedback treatment for ADHD in children and adolescents.

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Methods

Meta-Analysis

Inclusion criteria

studies have to assess NFB efficacy

subjects must have received a diagnosis of ADHD based on DSM, ICD-10 (67) criteria, or

by a qualified psychiatrist

be written in English, German,

Spanish, or French

include at least eight subjects

in each group

Research — Neurofeedback therapy for children and adolescents with ASD or ADHD

_ indis

Level & Quality of

Results . evidence

NF vcontrol for hyperactivity/impulsivity symptoms using probably blind evaluator: ES -0.16, 95% Cl -0.32, 0.01
NF v stimulant control group using most proximal evaluator: ES 0.26, 95% Cl 0.02, 0.51

16 included RCTs (n = 706) HIGH

e ES in favour of NF efficacy as being significant when clinical scales of ADHD are rated by parents (non-blind, p-value = 0.0014), but not when they are rated by teachers (probably blind, p-value = 0.27).

e The ES is significant according to both raters for the subset of studies meeting the definition of “standard NF protocols (parents’

Although results are in favour of NF when parents are rating/self-reporting effectiveness there is still the need for studies with placebo-controlled intervention as well as carefully reported neuro- marker changes in relation to clinical response to be performed.

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Table 3. Literature Review - ADHD

Author Aim/Objective Methods

e Aged below 25 years

Severity of ADHD symptoms assessed by parents (most proximal) or teachers (probably blinded). Measured using clinical scales such as the ADHD-RS which is a self-reported questionnaire.

Extensive explanation of meta- analysis methods provided. Sensitivity analysis and regression models conducted.

Yan, Wang [8] To perform asystematic Systematic review and meta- review and meta-analysis analysis of head-to-head RCTs comparing the effects of | PRISMA guidelines followed. methylphenidate (MPH - Ritalin) and NF in terms Eligibility of efficacyon ADHD core’ e children/adolescents <18 symptoms (combined, years) and/or adults 218 years

e RCTs only

Research — Neurofeedback therapy for children and adolescents with ASD or ADHD

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Results

p-value = 0.0054; teachers’ p- value = 0.043, k = 4)

e 3 main factors identified that have an impact on NF efficacy:

more intensive treatment, but

not treatment duration

teachers report a lower improvement compared to parents
Using high-quality EEG equipment improves the effectiveness of treatment.

18 RCTs included (778 individuals with ADHD in the NF arm and 757 in the MPH group)

At the study first endpoint, MPH was significantly more efficacious than NF on ADHD core symptoms (ADHD symptoms combined: SMD=-0.578,

Level & Quality of evidence

MODERATE

Differences in the dose of drugs, the number of feedbacks, which may introduce some bias in the statistical analyses.

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Table 3. Literature Review - ADHD

Author

inattention and

hyperactivity/impulsivity)

Aim/Objective

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Methods

e diagnosis of ADHD according to the DSM or ICD-10

e ADHD defined based on scores above cut-off point on any validated ADHD measure, as in previous meta-analyses

Interventions

Trials comparing head to head NF and MPH. Both fixed dose and flexible dose designs. Multimodal treatments were excluded to avoid confounding factors.

Only validated ADHD rating scales were included to determine treatment effectiveness.

Research — Neurofeedback therapy for children and adolescents with ASD or ADHD

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Results

95% Cl (-1.063 to -0.092)) and on two

neuropsychological parameters (inattention:—0.959 (-1.711 to — 0.208); inhibition:—0.469 (-0.872 to —0.066)).

Dropouts were significantly lower in NF versus MPH (OR=0.412, 0.186 to 0.913).

At the study follow-up, MPH was superior to NF in some outcomes, but results were inconsistent across raters (parents and teachers).

High risk of bias across studies due to concerns of allocation concealment. This may have contributed to placebo effects, which may affect the results.

Level & Quality of evidence

Inclusion of different rating scales to assess the core symptoms of ADHD.

In future studies, risk of bias should be reduced, in particular, blinding of outcome assessments.

At this stage there is still some uncertainty around results due to study quality. Results should be interpreted with caution.

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Revision History

Revision

Revised by

Cleared by

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Research

Summary of Revision

Complete update of literature and inclusion of treatment for

Jane

09/04/2021

2021/180 and 2019/0038

NED19/195669

This document has been completely revised. The initial document did not conduct a comprehensive review of the literature or

ASD and ADHD critically analyse any of the included papers. Most information was not peer reviewed and taken from website sources. This version now includes literature on the effectiveness of neurofeedback therapy for ASD and ADHD in children and adolescents.

6 References

Lansbergen MM, van Dongen-Boomsma M, Buitelaar JK, Slaats-Willemse D. ADHD and EEG- neurofeedback: a double-blind randomized placebo-controlled feasibility study. Journal of neural transmission [Internet]. 2011; 118(2):[275-84 pp.]. Available from: https://link.springer.com/content/pdf/10.1007/s00702-010-0524-2.pdf.
Marzbani H, Marateb HR, Mansourian M. Neurofeedback: A Comprehensive Review on System Design, Methodology and Clinical Applications. Basic Clin Neurosci [Internet]. 2016; 7(2):[143-58 pp.]. Available from: https://pubmed.ncbi.nlm.nih.gov/27303609.
van Hoogdalem LE, Feijs HME, Bramer WM, Ismail SY, van Dongen JDM. The effectiveness of neurofeedback therapy as an alternative treatment for autism spectrum disorders in children: A systematic review. Journal of Psychophysiology [Internet]. 2020:[No Pagination Specified-No Pagination Specified pp.].

4, Holtmann M, Steiner S, Hohmann S, Poustka L, Banaschewski T, Bolte S. Neurofeedback in autism spectrum disorders. Developmental Medicine & Child Neurology. 2011;53(11):986-93.

Bussalb A, Congedo M, Barthélemy Q, Ojeda D, Acquaviva E, Delorme R, et al. Clinical and Experimental Factors Influencing the Efficacy of Neurofeedback in ADHD: A Meta-Analysis. Frontiers in Psychiatry [Internet]. 2019 2019-February-18; 10(35). Available from: https://www.frontiersin.org/article/10.3389/fpsyt.2019.00035.
Cortese S, Ferrin M, Brandeis D, Holtmann M, Aggensteiner P, Daley D, et al. Neurofeedback for Attention-Deficit/Hyperactivity Disorder: Meta-Analysis of Clinical and Neuropsychological Outcomes From Randomized Controlled Trials. Journal of the American Academy of Child & Adolescent Psychiatry [Internet]. 2016 2016/06/01/; 55(6):[444-55 pp.]. Available from: https://www.sciencedirect.com/science/article/pii/SO890856716300958.

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 Riesco-Matías P, Yela-Bernabé JR, Crego A, Sánchez-Zaballos E. What Do Meta-Analyses

Have to Say About the Efficacy of Neurofeedback Applied to Children With ADHD? Review of Previous Meta-Analyses and a New Meta-Analysis. Journal of Attention Disorders [Internet]. 2021; 25(4):[473-85 pp.]. Available from: https://journals.sagepub.com/doi/abs/10.1177/1087054718821731. 8. Yan L, Wang S, Yuan Y, Zhang J. Effects of neurofeedback versus methylphenidate for the treatment of ADHD: systematic review and meta-analysis of head-to-head trials. Evidence Based Mental Health [Internet]. 2019; 22(3):[111 p.]. Available from: http://ebmh.bmj.com/content/22/3/111.abstract.

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