Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD

Completed · Not applicable · Has a placebo group

Conditions studied: Attention-Deficit/Hyperactivity Disorder

In brief

Additional treatments with long-term benefit for attention-deficit/hyperactivity disorder (ADHD) are needed; one of the more promising is neurofeedback (EEG biofeedback), which has several randomized controlled trials showing significant benefit, but which are inconclusive because they were not double-blinded; the benefit could have been nonspecific (placebo response). Because of neurofeedback's labor-intensive cost (1 treatment costing as much as a month's medication), It is important to know how much specific benefit it yields. This 2- site placebo-controlled double-blind randomized clinical trial is the first to test for a specific benefit of neurofeedback with adequate power, the first designed and implemented collaboratively by experts in neurofeedback, ADHD, and clinical trials, the first to rigorously monitor quality not only of treatment, but also of placebo and blinding, and the first to follow up for 2 years to examine enduring effect; the results, whether positive or negative, will provide evidence for clinical practice and public policy regarding ADHD.

Key facts

Study ID

NCT02251743

Run by

Ohio State University

People needed

144

Starts

2014-09-01

Expected to finish

2020-08-01

Last updated by the study team

2020-09-29

Who can join

Age: 7 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Boys and girls age 7 to 10
• IQ>80
• diagnosed DSM-5 ADHD inattentive presentation or combined presentation
• an item mean ≥1.5 sd above norms on a 0-3 metric both on parent ratings of either DSM-IV inattentive symptoms or all 18 ADHD symptoms and on teacher ratings of either inattentive symptoms or all 18 ADHD symptoms
• an eyes-open QEEG with theta-beta power ratio >4.5 at Cz or Fz

You may not qualify if…

• comorbid disorder requiring psychoactive medication other than FDA-approved ADHD medication
• a medical disorder requiring systemic chronic medication with confounding psychoactive effects
• sleep apnea
• restless legs syndrome
• IQ <80
• plans to move requiring school change during the next 3 months
• plans to start other ADHD treatment in the next 3 months
• antipsychotic agent in the 6 months prior to baseline assessment
• fluoxetine in the 4 weeks prior to baseline
• other psychiatric medication in the two weeks prior to baseline
• >5 previous NF treatments
• Vitamin D deficiency will be a temporary exclusion

Where it is running

• University of North Carolina at Asheville — Asheville, North Carolina, United States
• The Ohio State University Nisonger Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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