A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy. (July 2013)

• Record Type: Journal Article
• Authors: Kerson, Cynthia
• Is Part Of: Journal of attention disorders. Volume 17:Number 5(2013)
• Page Start: 420
• Page End: 436
• Publication Date: 2013-07
• Subjects: ADHD -- neurofeedback -- double-blind -- randomized clinical trial; Attention-deficit hyperactivity disorder -- Periodicals; Attention -- Periodicals; 616.8589
• DOI: 10.1177/1087054713482580
• Languages: English
• ISSNs: 1087-0547

Abstract

Objective: Additional treatments with persisting benefit are needed for ADHD. Because ADHD often shows excessive theta electroencephalogram (EEG) power, low beta, and excessive theta-beta ratio (TBR), a promising treatment is neurofeedback (NF) downtraining TBR. Although several nonblind randomized clinical trials (RCTs) show a medium-large benefit for NF, a well-blinded, sham-controlled RCT is needed to differentiate specific from nonspecific effects.Method: Experts in NF, ADHD, clinical trials, and statistics collaborated to design a double-blind multisite RCT.Results/Conclusion: At four sites, 180 children aged 7 to 10 years with rigorously diagnosed ADHD and TBR ≥ 5 will be randomized to active TBR-NF versus sham NF of equal duration, intensity, and appearance. Sham, utilizing prerecorded EEGs with participant artifacts superimposed, will keep participants and staff blind. Treatment fidelity will be trained/monitored by acknowledged NF leaders. Multidomain assessments before, during, and after treatment (follow-up to 2 years) will also include tests of blinding and sham inertness.