Status:
COMPLETED
Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD
Lead Sponsor:
Ohio State University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
University of North Carolina
Conditions:
Attention-Deficit/Hyperactivity Disorder
Eligibility:
All Genders
7-10 years
Phase:
NA
Brief 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 ...
Detailed Description
Current established, evidence-based treatments for attention-deficit/hyperactivity disorder (ADHD) are incompletely effective and not universally acceptable, and appear to wane in effect over time des...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2020
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT02251743
Start Date
September 1 2014
End Date
August 1 2020
Last Update
September 29 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of North Carolina at Asheville
Asheville, North Carolina, United States, 28804
2
The Ohio State University Nisonger Center
Columbus, Ohio, United States, 43215