Pilot Feasibility Study of Neurofeedback for Attention Deficit Hyperactivity Disorder (ADHD)
|ClinicalTrials.gov Identifier: NCT00886483|
Recruitment Status : Completed
First Posted : April 23, 2009
Results First Posted : November 28, 2013
Last Update Posted : November 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Device: Active Neurofeedback Device: Sham neurofeedback||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pilot Explorations of Neurofeedback Issues in ADHD|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||June 2011|
Active Comparator: Active neurofeedback
In the active neurofeedback condition, the intervention is active neurofeedback (actual neurofeedback) either twice weekly or three times a week (randomized to frequency), with the same amount of total treatment over 40 sessions, varying only in frequency. Neurofeedback will be via the CyberLearning technology, using videogame race car speed and steering as feedback governed by EEG theta-beta ratio through the interface. the game controller is used in the usual fashion, but maximal speed is capped by the threshold theta-beta ratio, which changes from minute-to-minute by fuzzy logic based on the previous minute's ratio. If theta power exceeds a threshold, the rumble function of the controller comes on as a warning. The feedback is transparent to the patient, who just plays the videogame.
Device: Active Neurofeedback
A comparison of active neurofeedback to sham neurofeedback and of two treatment schedules: twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
Other Name: Electroencephalographic biofeedback, EEG biofeedback
Sham Comparator: Sham Neurofeedback
The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
Device: Sham neurofeedback
Active neurofeedback vs. sham neurofeedback for 40 treatments, either twice or three times per week.
Other Name: Electroencephalographic biofeedback or EEG biofeedback
- Feasibility of Double-blind, Sham-controlled Design #1. Recruitment Number [ Time Frame: 2 years ]The feasibility of the double-blind, sham-controlled design was examined in 3 ways, this first way was via the number of participants recruited.
- Feasibility of Double-blind, Sham-controlled Design #2. Retention [ Time Frame: 40th treatment sessions ~ 13-20 weeks ]The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The second way was via the percentage of participants retained the end of treatment (40th session).
- Feasibility of Double-blind, Sham-controlled Design #3. Validity of Blind [ Time Frame: Post-treatment at session 40 ]The feasibility of the double-blind, sham-controlled design was examined in 3 ways. The 3rd way was the percentage of child and parent post-hoc guess regarding treatment assignment.
- Frequency Advisability Outcome (2X vs. 3X/wk) #1 Parent & Child Satisfaction [ Time Frame: 24 treatments ~ 8-12 weeks ]Parent & child satisfaction of treatment frequency (x2 vs x3 treatments per week) was measured on a likert scale with anchors 0 (indicating low satisfaction) and 7 (indicating high satisfaction).
- Frequency Advisability Outcome (2X vs. 3X/wk) #2. Treatment Frequency Choice [ Time Frame: 24 treatments ~ 8-12 weeks ]Treatment frequency preference when given choice to change or not to change treatment frequency from 2 to 3X/wk or 3 to 2X/wk at treatment # 24.
- Necessary Duration of Treatment [ Time Frame: 40 treatment sessions ~ 13-20 weeks ]The necessary duration of treatments was examined via identifying the number of treatments at which improvement stabilized, as shown visually on graphs of parent-rated ADHD symptoms from the SNAP-IV (0-3 scale, lower score is better) for those participants in the Active Neurofeedback who completed 40 treatment sessions.The Sham group is not included in this outcome.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886483
|United States, Ohio|
|The Ohio State University Nisonger Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||L. Eugene Arnold, M.Ed., M.D.||Ohio State University|