An Evaluation of Neurofeedback Efficacy in Adults With ADHD
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|ClinicalTrials.gov Identifier: NCT01852357|
Recruitment Status : Completed
First Posted : May 13, 2013
Last Update Posted : October 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Other: Neurofeedback Other: Sham Neurofeedback||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Placebo-Control Evaluation of Neurofeedback Efficacy in Adults With ADHD|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Sham Comparator: Sham control
This group will receive 12 sham neurofeedback sessions in which the feedback is based on pre-recorded data.
Other: Sham Neurofeedback
Feedback generated by data not associated with the current participant.
The intervention will be 24 sessions of beta/SMR neurofeedback.
The intervention will be 24 sessions of beta/sensorimotor rhythm (SMR) neurofeedback.
Other Name: EEG biofeedback
- Attention Performance Index of the Test of Variables of Attention [ Time Frame: After 12 neurofeedback or sham sessions (an average of 4 weeks). ]The primary outcome will be change from baseline on the Attention Performance Index (API) variable of the Test of Variables of Attention (TOVA) a standardized, well-normed, computerized test of attention, after 12 neurofeedback or sham training sessions (an average of 4 weeks).
- Test of Variables of Attention [ Time Frame: after 12 (average 4 weeks) and 24 sessions (average 8 weeks) and 1 month followup ]Secondary outcomes will be change from baseline on other TOVA variables after 12 and 24 sessions (4 and 8 weeks on average, respectively), at 4 weeks post-training follow-up
- Adult Self-Report Scale [ Time Frame: after 12 and 24 sessions (average of 4 and 8 weeks, respectively), 1 month followup ]A self report survey of ADHD symptoms.
- Mindful Awareness and Attention Scale [ Time Frame: after 12 and 24 sessions (average of 4 and 8 weeks, respectively) and 1 month followup ]A self report scale that assesses mindful attention and awareness.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852357
|United States, North Carolina|
|Department of Psychology, UNC Wilmington|
|Wilmington, North Carolina, United States, 28403|
|Principal Investigator:||Julian R Keith, Ph.D||University of North Carolina, Wilmington|