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

NCT02251743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2020-09-29

Study results available
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Summary

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.

Conditions

  • Attention-Deficit/Hyperactivity Disorder

Interventions

DEVICE

Neurofeedback treatment

Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks: 1. The number of half-second periods that they met the reward parameters (i.e. theta mV below threshold; beta mV above threshold) 2. Average voltage of theta waves 3. Average voltage of beta 4. Average ratio of theta to beta power (TBR)

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • University of North Carolina

    collaborator OTHER

  • Ohio State University

    lead OTHER

Principal Investigators

  • L. Eugene Arnold, MD, MEd · The Ohio State University Nisonger Center

  • Roger deBeus, Ph.D. · University of North Carolina at Asheville

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2019-04-30
Completion
2020-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02251743 on ClinicalTrials.gov