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Editorial: Neurofeedback in Attention-Deficit/Hyperactivity Disorder: Still No Evidence of Specific Effects
Abstract
The Neurofeedback Collaborative Group presents the results from a 25-month follow-up, randomized controlled study of theta/beta ratio (TBR) down-training electroencephalography neurofeedback (EEG-NF).1 NF is a computer-based training with real-time brain activity- contingent feedback in the form of a game with audio-visual rewards. These rewards aim to reinforce learning of neural activity patterns related to attention or behavioral control. The down-training of the TBR is considered a standard protocol of EEG-NF. The same group has previously published their findings about effects at the end of treatment and 13-month follow-up without evidence of specific NF effects on the primary outcome, a composite score of parent and teacher ratings of inattention. However, participants in the NF group had less need for medication than those in the control group.2 This randomized controlled trial has several strengths, including a sophisticated "sham NF," excellent blinding of parents and investigators, fidelity procedures, and the use of a standard protocol in a population with elevated TBR. The control group was designed to overcome some of the downsides of previous sham-NF protocols by matching the patient's artifacts on the control electroencephalogram. In their current publication, the Neurofeedback Collaborative Group focuses on the possibility of delayed therapeutic NF effects that are thought to be due to the progressive learning of brain activity control.3 These putative delayed effects and lasting benefits are essential issues in determining the utility of NF in ADHD, because previous studies with blinded or probably-blinded assessments showed no short-term differences between NF and control conditions.4 Results confirm the pre-post effect sizes of previous studies, without significant group differences at the 25-month assessment, indicated that there are no specific effects of the NF training paradigm. This is in line with another recent randomized sham-controlled trial with functional magnetic resonance imaging-NF showing no group differences either on the clinical primary outcome or on cognitive functioning in children with attention-deficit/hyperactivity disorder (ADHD).5.
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We examined psychiatric comorbidities moderation of a 2-site double-blind randomized clinical trial of theta/beta-ratio (TBR) neurofeedback (NF) for attention deficit hyperactivity disorder (ADHD). Seven-to-ten-year-olds with ADHD received either NF (n = 84) or Control (n = 58) for 38 treatments. Outcome was change in parent-/teacher-rated inattention from baseline to end-of-treatment (acute effect), and 13-month-follow-up. Seventy percent had at least one comorbidity: oppositional defiant disorder (ODD) (50%), specific phobias (27%), generalized anxiety (23%), separation anxiety (16%). Comorbidities were grouped into anxiety alone (20%), ODD alone (23%), neither (30%), or both (27%). Comorbidity (p = 0.043) moderated acute effect; those with anxiety-alone responded better to Control than to TBR NF (d = − 0.79, CI − 1.55– − 0.04), and the other groups showed a slightly better response to TBR NF than to Control (d = 0.22 ~ 0.31, CI − 0.3–0.98). At 13-months, ODD-alone group responded better to NF than Control (d = 0.74, CI 0.05–1.43). TBR NF is not indicated for ADHD with comorbid anxiety but may benefit ADHD with ODD.
Clinical Trials Identifier: NCT02251743, date of registration: 09/17/2014
To elucidate possible additive effects of electroencephalogram-based neurofeedback (EEG-NF) on medications against the core symptoms of attention-deficit/hyperactivity disorder (ADHD), randomized controlled trials (RCTs) were retrieved from electronic databases including PubMed, EMBASE, ClinicalKey, Cochrane CENTRAL, ScienceDirect, and ClinicalTrials.gov from inception to March 2022. The primary outcomes were changes in ADHD symptoms (i.e., global, inattention, hyperactivity/impulsivity) assessed with validated rating scales, while secondary outcome was all-cause discontinuation rate. Meta-analysis of five RCTs involving 305 participants [Median age = 9.285 years (range 8.6–11.05)] with a median follow-up of 12 weeks showed additive effects of EEG-NF on medications from parents’ observations against ADHD global symptoms (Hedges’ g = 0.2898, 95%CI [0.0238; 0.5557]) and inattention symptoms (Hedges’ g = 0.3274, 95%CI [0.0493; 0.6055]). However, additive effects failed to sustain six months after EEG-NF intervention. Besides, there was no difference in improvement of hyperactivity/impulsivity from parents’ observation, attentional performance, and all-cause discontinuation rate between the two groups. Our results supported additional benefits of combining EEG-NF with medications compared to medication alone in treating global symptoms and symptoms of inattention in ADHD patients. Nevertheless, given a lack of evidence showing a correlation between underlying physiological changes and small effect sizes in our preliminary results, further studies are warranted to support our findings.
Objective
To determine whether theta/beta-ratio (TBR) electroencephalographic biofeedback (neurofeedback, NF) has a specific effect on attention-deficit/hyperactivity disorder (ADHD) beyond nonspecific benefit.
Method
In a 2-site double-blind randomized clinical trial, 144 children age 7-10 with rigorously diagnosed moderate/severe ADHD and theta/beta-ratio (TBR)>4.5 were randomized 3:2 to deliberate TBR downtraining vs. a control of equal duration, intensity, and appearance. Two early dropouts left 142 for modified intent-to-treat analysis. The control utilized pre-recorded EEGs with participant’s artifacts superimposed. Treatment was programmed via internet by an off-site statistician-guided co-investigator. Fidelity was 98.7% by trainers/therapists, 93.2% by NF expert monitor. Primary outcome was parent- and teacher-rated inattention; analysis was mixed-effects regression. Because expense and effort of NF can be justified only by enduring benefit, follow-ups were integrated.
Results
Blinding was excellent. While both groups showed significant improvement (p<0.001, d=1.5) in parent/teacher rated inattention from baseline to treatment-end and 13-month follow-up, NF was not significantly superior to the control condition at either time point on this primary outcome (d=0.01, p=0.965 at treatment end; d=0.23, p=.412 at 13-month follow-up). Responders (CGI-I=1-2) were 61% of NF and 54% of Controls (p=.36). Adverse events were distributed proportionally between treatments. 13–month follow-up found nonsignificant improvement from treatment end for NF (d=0.1), with mild deterioration for controls (d= -0.07). NF required significantly less medication at follow-up (p=.012).
Conclusion
This study does not support a specific effect of deliberate TBR NF at either treatment end or 13-month follow-up. Participants will be reassessed at 25-month follow-up.
Objective:
We propose that clinicians can use suggestion to help treat conditions such as ADHD.
Methods:
We use EEG neurofeedback as a case study, alongside evidence from a recent pilot experiment utilizing a sham MRI scanner to highlight the therapeutic potential of suggestion-based treatments.
Results:
The medical literature demonstrates that many practitioners already prescribe treatments that hardly outperform placebo comparators. Moreover, the sham MRI experiment showed that, even with full disclosure of the procedure, suggestion alone can reduce the symptomatology of ADHD.
Conclusion:
Non-deceptive suggestion-based treatments, especially those drawing on accessories from neuroscience, may offer a safe complement and potential alternative to current standard of care for individuals with ADHD.
Neurofeedback (NF) has gained increasing interest in the treatment of attention-deficit/hyperactivity disorder (ADHD). Given learning principles underlie NF, lasting clinical treatment effects may be expected. This systematic review and meta-analysis addresses the sustainability of neurofeedback and control treatment effects by considering randomized controlled studies that conducted follow-up (FU; 2-12 months) assessments among children with ADHD. PubMed and Scopus databases were searched through November 2017. Within-group and between-group standardized mean differences (SMD) of parent behavior ratings were calculated and analyzed. Ten studies met inclusion criteria (NF: ten studies, N = 256; control: nine studies, N = 250). Within-group NF effects on inattention were of medium effect size (ES) (SMD = 0.64) at post-treatment and increased to a large ES (SMD = 0.80) at FU. Regarding hyperactivity/impulsivity, NF ES were medium at post-treatment (SMD = 0.50) and FU (SMD = 0.61). Non-active control conditions yielded a small significant ES on inattention at post-treatment (SMD = 0.28) but no significant ES at FU. Active treatments (mainly methylphenidate), had large ES for inattention (post: SMD = 1.08; FU: SMD = 1.06) and medium ES for hyperactivity/impulsivity (post: SMD = 0.74; FU: SMD = 0.67). Between-group analyses also revealed an advantage of NF over non-active controls [inattention (post: SMD = 0.38; FU: SMD = 0.57); hyperactivity-impulsivity (post: SMD = 0.25; FU: SMD = 0.39)], and favored active controls for inattention only at pre-post (SMD = - 0.44). Compared to non-active control treatments, NF appears to have more durable treatment effects, for at least 6 months following treatment. More studies are needed for a properly powered comparison of follow-up effects between NF and active treatments and to further control for non-specific effects.
Objective:
Functional MRI neurofeedback (fMRI-NF) could potentially be a novel, safe nonpharmacological treatment for attention deficit hyperactivity disorder (ADHD). A proof-of-concept randomized controlled trial of fMRI-NF of the right inferior frontal cortex (rIFC), compared to an active control condition, showed promising improvement of ADHD symptoms (albeit in both groups) and in brain function. However, comparison with a placebo condition in a larger trial is required to test efficacy.
Methods:
This double-blind, sham-controlled randomized controlled trial tested the effectiveness and efficacy of fMRI-NF of the rIFC on symptoms and executive functions in 88 boys with ADHD (44 each in the active and sham arms). To investigate treatment-related changes, groups were compared at the posttreatment and 6-month follow-up assessments, controlling for baseline scores, age, and medication status. The primary outcome measure was posttreatment score on the ADHD Rating Scale (ADHD-RS).
Results:
No significant group differences were found on the ADHD-RS. Both groups showed similar decreases in other clinical and cognitive measures, except for a significantly greater decrease in irritability and improvement in motor inhibition in sham relative to active fMRI-NF at the posttreatment assessment, covarying for baseline. There were no significant side effects or adverse events. The active relative to the sham fMRI-NF group showed enhanced activation in rIFC and other frontal and temporo-occipital-cerebellar self-regulation areas. However, there was no progressive rIFC upregulation, correlation with ADHD-RS scores, or transfer of learning.
Conclusions:
Contrary to the hypothesis, the study findings do not suggest that fMRI-NF of the rIFC is effective in improving clinical symptoms or cognition in boys with ADHD.
Objective:
We performed meta-analyses of randomized controlled trials to examine the effects of neurofeedback on attention-deficit/hyperactivity disorder (ADHD) symptoms and neuropsychological deficits in children and adolescents with ADHD.
Method:
We searched PubMed, Ovid, Web of Science, ERIC, and CINAHAL through August 30, 2015. Random-effects models were employed. Studies were evaluated with the Cochrane Risk of Bias tool.
Results:
We included 13 trials (520 participants with ADHD). Significant effects were found on ADHD symptoms rated by assessors most proximal to the treatment setting, that is, the least blinded outcome measure (standardized mean difference [SMD]: ADHD total symptoms = 0.35, 95% CI = 0.11-0.59; inattention = 0.36, 95% CI = 0.09-0.63; hyperactivity/impulsivity = 0.26, 95% CI = 0.08-0.43). Effects were not significant when probably blinded ratings were the outcome or in trials with active/sham controls. Results were similar when only frequency band training trials, the most common neurofeedback approach, were analyzed separately. Effects on laboratory measures of inhibition (SMD = 0.30, 95% CI = -0.10 to 0.70) and attention (SMD = 0.13, 95% CI = -0.09 to 0.36) were not significant. Only 4 studies directly assessed whether learning occurred after neurofeedback training. The risk of bias was unclear for many Cochrane Risk of Bias domains in most studies.
Conclusion:
Evidence from well-controlled trials with probably blinded outcomes currently fails to support neurofeedback as an effective treatment for ADHD. Future efforts should focus on implementing standard neurofeedback protocols, ensuring learning, and optimizing clinically relevant transfer.