Status:
COMPLETED
Pilot Feasibility Study of Neurofeedback for Attention Deficit Hyperactivity Disorder (ADHD)
Lead Sponsor:
L. Eugene Arnold
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Brain Resource Center
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-12 years
Phase:
NA
Brief Summary
Neurofeedback is increasingly advocated for treatment of ADHD despite a thin evidence base. The numerous open and partially controlled studies suffer serious design flaws. In particular, there is no p...
Detailed Description
Thirty-nine boys and girls aged 6-12 with rigorously diagnosed DSM-IV ADHD not currently taking medication will be twice-randomized: first to active neurofeedback (n=26) vs. sham neurofeedback (n=13),...
Eligibility Criteria
Inclusion
- Age 6-12 inclusive.
- Boys and girls.
- Primary diagnosis of ADHD, inattentive or combined type.
- Not currently taking medication for ADHD.
- Primary caretaker who can provide frequent parent ratings.
- Item mean ≥1.5 on a 0-3 metric on parent/teacher ratings of DSM-IV inattentive symptoms or on parent/teacher ratings of all 18 ADHD symptoms (while off medication).
- IQ 80 or above and mental age of 6 years or more.
- Willingness and ability to come for 40 treatment sessions and to cooperate with assessments.
- Informed consent and assent
Exclusion
- Comorbid disorder requiring psychoactive medication including psychosis, bipolar disorder, severe major depression, and severe anxiety disorders. Patients with mild depression or anxiety not requiring pharmacotherapy will be included and the comorbid symptoms will be tracked.Pervasive developmental disorder is exclusionary by DSM-IV definition of ADHD.
- Medical disorder requiring systemic chronic medication that has confounding psychoactive effects. Asthma inhalants will be allowed, but not chronic systemic corticoids.
- Mental Retardation.
- Anything that would interfere with assessments or study treatment or contraindicate study treatment.
- Plans to move requiring school change during the next 4 months.
- Antipsychotic agent in the 6 months prior to baseline assessment, fluoxetine or atomoxetine in the 4 weeks prior to baseline, stimulant in the week prior to baseline, or other psychiatric medication in the two weeks prior to baseline.
- Previous neurofeedback training of more than 5 treatments.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00886483
Start Date
August 1 2008
End Date
June 1 2011
Last Update
November 11 2016
Active Locations (1)
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1
The Ohio State University Nisonger Center
Columbus, Ohio, United States, 43210