- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02251743
Double-Blind 2-Site Randomized Clinical Trial of Neurofeedback for ADHD
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Asheville, North Carolina, United States, 28804
- University of North Carolina at Asheville
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Ohio
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Columbus, Ohio, United States, 43215
- The Ohio State University Nisonger Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Neurofeedback treatment
The intended treatment is downtraining of theta power and uptraining of beta power for 38 treatments of active NF.
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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:
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Placebo Comparator: Sham neurofeedback treatment
Participants assigned to sham and their trainers will be fed EEG data from pre-recorded files (recorded during live clinical NF) rather than from the participant's live signal.
In order to prevent unblinding of experienced NF trainers/technicians, artifacts from the participant's EMG and EOG are blended into the pre-recorded EEG so that the trainer controlling the feedback cannot differentiate between live and simulated data.
To insure trainer/technician blindness, the pre-recorded EEG will be 38 consecutive EEGs from the same age-matched clinical case so that EEGs of the sham group will also show "training progress" over successive sessions, like real NF.
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scores of Teacher and Parent Rated Inattentive Symptoms
Time Frame: Assessed at Baseline, Mid-treatment (2 months), End-treatment (4 months), at 6 month follow up, at 13 month follow up
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The primary outcome measure is the composite scores of teacher and parent-rated inattentive symptoms on the Conners-3, rated on a scale of 0-3.
Lower scores represent a better outcome, with a maximum score of 3 and a minimum score of 0.
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Assessed at Baseline, Mid-treatment (2 months), End-treatment (4 months), at 6 month follow up, at 13 month follow up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: L. Eugene Arnold, MD, MEd, The Ohio State University Nisonger Center
- Principal Investigator: Roger deBeus, Ph.D., University of North Carolina at Asheville
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013H0417
- 1R01MH100144-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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