title: A proposed multisite double-blind randomized clinical trial of neurofeedback for ADHD: need, rationale, and strategy.
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.
  
  
  METHODS
  Experts in NF, ADHD, clinical trials, and statistics collaborated to design a double-blind multisite RCT.
  
  
  CONCLUSIONS
  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.
authors.affiliation: ISNR Research Foundation, San Rafael, CA 94901, USA. executivedirector@isnr-researchfoundation.org
authors.forename: Cynthia
authors.initials: C
authors.lastname: Kerson
mesh_terms: D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000503:physiopathology* / Q000628:therapy*; D001611:Beta Rhythm; D002540:Cerebral Cortex / Q000503:physiopathology*; D002648:Child; D004311:Double-Blind Method; D004569:Electroencephalography; D005240:Feasibility Studies; D005246:Feedback; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D058765:Neurofeedback / Q000502:physiology*; D010552:Personality Assessment; D010865:Pilot Projects; D012815:Signal Processing, Computer-Assisted; D013826:Theta Rhythm
keywords: ADHD; double-blind; neurofeedback; randomized clinical trial