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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham control | Sham Comparator | This group will receive 12 sham neurofeedback sessions in which the feedback is based on pre-recorded data. |
|
| Neurofeedback | Experimental | The intervention will be 24 sessions of beta/SMR neurofeedback. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neurofeedback | Other | The intervention will be 24 sessions of beta/sensorimotor rhythm (SMR) neurofeedback. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attention Performance Index of the Test of Variables of Attention | 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). | After 12 neurofeedback or sham sessions (an average of 4 weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Test of Variables of Attention | 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 | after 12 (average 4 weeks) and 24 sessions (average 8 weeks) and 1 month followup |
| Measure | Description | Time Frame |
|---|---|---|
| Adult Self-Report Scale | A self report survey of ADHD symptoms. | after 12 and 24 sessions (average of 4 and 8 weeks, respectively), 1 month followup |
| Mindful Awareness and Attention Scale | A self report scale that assesses mindful attention and awareness. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julian R Keith, Ph.D | University of North Carolina, Wilmington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychology, UNC Wilmington | Wilmington | North Carolina | 28403 | United States |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham Neurofeedback | Other | Feedback generated by data not associated with the current participant. |
|
| after 12 and 24 sessions (average of 4 and 8 weeks, respectively) and 1 month followup |
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |