Department of Psychology, UNC Wilmington
Wilmington, North Carolina, 28403, United States
NCT Number: NCT01852357
The primary objective of this study is to evaluate the effectiveness of neurofeedback training (NFB) on objective measurements of attention in young adults with ADHD. The secondary objectives are to evaluate neurofeedback effects on self-report measures of attention, ADHD symptoms, and to identify electroencephalogram (EEG) markers of ADHD and neurofeedback efficacy. The study is a double-blind, placebo controlled clinical trial to test the efficacy and safety of EEG neurofeedback in individuals 18-40 years of age with attention deficit hyperactivity disorder (ADHD). Attention will be evaluated at baseline, after 12 and 24 training sessions (an average of 4 and 8 weeks, respectively), and 4 weeks after the last neurofeedback session. 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 (and average of 4 weeks). Secondary outcomes will be change from baseline on other TOVA variables after 12 and 24 sessions (an average of 4 and 8 weeks, respectively), at 4 weeks post-training follow-up, and changes from baseline at each time point on the Adult Self Report Scale (ASRS) and Mindful Awareness and Attention Scale (MAAS). EEG data collected during TOVA attention testing at baseline will be used to model EEG differences between ADHD and non-ADHD participants. Additional EEG data collected during the TOVA at midpoint (average of 4 weeks), after 24 NFB sessions (average of 8 weeks), and 4 weeks post-NFB will be used to develop statistical models to use as indicators of neurofeedback efficacy
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Wilmington, North Carolina, 28403, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The intervention will be 24 sessions of beta/sensorimotor rhythm (SMR) neurofeedback.
Other names: EEG biofeedback
Feedback generated by data not associated with the current participant.
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).
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
Time frame: after 12 and 24 sessions (average of 4 and 8 weeks, respectively), 1 month followup
A self report survey of ADHD symptoms.
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.
University of North Carolina, Wilmington
Other
A Placebo-Control Evaluation of Neurofeedback Efficacy in Adults With ADHD
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