A randomized placebo-controlled trial of electroencephalographic (EEG) neurofeedback in children with
Martine van Dongen-Boomsma1, Madelon A Vollebregt, Dorine Slaats-Willemse
1Reinier Postlaan 12, 6525 GC Nijmegen, The Netherlands m.vandongen-boomsma@karakter.com.
Insights
Electroencephalographic (EEG) neurofeedback did not show superiority over placebo for treating attention-deficit/hyperactivity disorder (ADHD) in children. ADHD symptoms improved in both groups, but the difference was not statistically significant, indicating no added benefit from EEG neurofeedback.
Area of Science:
- Neuroscience
- Child Psychiatry
- Clinical Psychology
Background:
- Attention-deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children.
- Electroencephalographic (EEG) neurofeedback is a non-pharmacological intervention explored for ADHD treatment.
- Previous research on EEG neurofeedback for ADHD has yielded mixed results, necessitating rigorous investigation.
Purpose of the Study:
- To evaluate the efficacy and safety of EEG neurofeedback compared to placebo in children diagnosed with ADHD.
- To determine if EEG neurofeedback offers a significant improvement in ADHD symptom severity over a placebo intervention.
- To assess clinical global improvement as a secondary outcome measure.
Main Methods:
- A double-blind, randomized, placebo-controlled study involving 41 children (aged 8-15) with ADHD.
- Participants received 30 sessions of either EEG neurofeedback or placebo neurofeedback, twice weekly.
- Primary outcome measured by ADHD Rating Scale IV; secondary outcome by Clinical Global Impressions-Improvement scale (CGI-I).
Main Results:
- Both EEG neurofeedback and placebo groups showed improvement in total ADHD symptoms over time.
- No statistically significant difference in ADHD symptom severity or clinical global improvement was found between the groups.
- No clinically relevant side effects were reported, and treatment assignment could not be guessed by participants or parents.
Conclusions:
- EEG neurofeedback was not found to be superior to placebo neurofeedback in reducing ADHD symptoms in children.
- The study suggests that the observed improvements may be attributable to placebo effects or natural symptom fluctuation.
- Further research is needed to clarify the role of neurofeedback in managing pediatric ADHD.
Objective:
A double-blind, randomized, placebo-controlled study was designed to assess the efficacy and safety of electroencephalographic (EEG) neurofeedback in children with attention-deficit/hyperactivity disorder (ADHD). The study started in August 2008 and ended in July 2012 and was conducted at Karakter Child and Adolescent Psychiatry University Centre in Nijmegen, The Netherlands.
Method:
Forty-one children (aged 8-15 years) with a DSM-IV-TR diagnosis of ADHD were randomly assigned to treatment with either EEG neurofeedback (n = 22) or placebo neurofeedback (n = 19) for 30 sessions, given as 2 sessions per week. The children were stratified by age, electrophysiologic state of arousal, and medication use. Everyone involved in the study, except the neurofeedback therapist and the principal investigator, was blinded to treatment assignment. The primary outcome was severity of ADHD symptoms on the ADHD Rating Scale IV, scored at baseline, during treatment, and at study end. Clinical improvement as measured by the Clinical Global Impressions-Improvement scale (CGI-I) was a secondary outcome.
Results:
While total ADHD symptoms improved over time in both groups (F1,39 = 26.56, P < .001), there was no significant treatment effect, ie, group × time interaction (F1,39 = 0.36, P = .554); the same was true for clinical improvement as measured by the CGI-I (P = .092). No clinically relevant side effects were observed. Among the children and their parents, guessing treatment assignment was not better than chance level (P = .224 for children, P = .643 for parents).
Conclusion:
EEG neurofeedback was not superior to placebo neurofeedback in improving ADHD symptoms in children with ADHD.
Trial Registration:
ClinicalTrials.gov identifier: NCT00723684.
