A Proposed Multisite Double-Blind Randomized Clinical Trial of Neurofeedback for ADHD: Need, Rationale, and Strategy

Neurofeedback Collaborative Group

Research output: Contribution to journalArticleAcademicpeer-review

30 Citations (Web of Science)

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.

Original languageEnglish
Pages (from-to)420-436
Number of pages17
JournalJournal of Attention Disorders
Volume17
Issue number5
DOIs
Publication statusPublished - Jul 2013
Externally publishedYes

Keywords

  • ADHD
  • neurofeedback
  • double-blind
  • randomized clinical trial
  • ATTENTION-DEFICIT/HYPERACTIVITY DISORDER
  • DEFICIT-HYPERACTIVITY DISORDER
  • SLOW CORTICAL POTENTIALS
  • VOLUNTARY CONTROL
  • SENSORIMOTOR RHYTHM
  • SELECTIVE ATTENTION
  • QUANTITATIVE EEG
  • CHILDREN
  • STIMULANTS
  • IMPULSIVITY

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