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J Atten Disord. 2013 Jul;17(5):420-36. doi: 10.1177/1087054713482580. Epub 2013 Apr 16.

A proposed multisite double-blind randomized clinical trial of neurofeedback for ADHD: need, rationale, and strategy.

Author information

1
ISNR Research Foundation, San Rafael, CA 94901, USA. executivedirector@isnr-researchfoundation.org

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.

KEYWORDS:

ADHD; double-blind; neurofeedback; randomized clinical trial

PMID:
23590978
DOI:
10.1177/1087054713482580
[Indexed for MEDLINE]

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