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This study evaluates the efficacy of the Neuro+ Attention Training System (Neuro+) in improving attention skills in children. Half of participants will receive the Neuro+ intervention for 10 weeks, while the other half will continue treatment as usual (TAU) for the same period. We expect those receiving the Neuro+ intervention to see significant improvements in ADHD symptoms relative to the TAU controls.
Neuro+ a non-pharmacological intervention that targets the underlying neural signatures and cognitive deficits which are assumed to mediate attention pathways. Targeting those underlying areas could reduce ADHD symptoms and potentially lead to greater transfer and generalization to functioning in the classroom and every day life.
Neuro+ combines neurofeedback, biofeedback, and go/no-go training protocols embedded in a training video game to help develop and improve attention skills. The protocols function as follows:
Neurofeedback: Users wear a dry, wireless, easy-to-use EEG headset that interfaces with computer software to provide feedback on their level of brain activation, or focus. Users must focus in order to advance through the training game.
Motion-biofeedback: Accelerometers in the headset send data on users' movement to the training game, such that users must maintain complete control of their bodies and remain absolutely still in order to advance through the game and avoid costly point penalties.
Go/no-go training: To practice impulse control, users will be challenged with adaptive "go/no-go tasks," requiring them to quickly and accurately respond to target stimuli and ignore distractions, with the tasks becoming more difficult as the user improves.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neuro+ Intervention | Experimental | 30 sessions (900 minutes) of Neuro+ Attention Training administered over 10 weeks. |
|
| Treatment as Usual | Active Comparator | Continuation of current treatment for ADHD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neuro+ Attention Training | Behavioral | Attention training program with Neuro+ software |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in ADHD symptoms with Quotient ADHD System assessment | Assessments to be conducted with the Quotient ADHD System | At screening and at final clinical visit within 1 week following intervention |
| Change in assessment of ADHD symptoms with Conners 3-Parent rating scale | Assessments to be conducted with the Conners 3-Parent rating scale | At screening and at final clinical visit within 1 week following intervention |
| Incidence of adverse events | Self-reported incidence of adverse events | As reported by subjects at final clinical visit, which occurs within 1 week following intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported convenience ratings of Neuro+ intervention | As evaluated on a Likert scale, the extent to which subjects and parents found the Neuro+ intervention convenient/easy-to-use | At final clinical visit, within 1 week following intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandeep Vaishnavi, MD, PhD | Carolina Partners in Mental HealthCare, PLLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neuropsychiatric Clinic at Carolina Partners in Mental HealthCare | Raleigh | North Carolina | 27609 | 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 |
|---|---|
| D013812 | Therapeutics |
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| Treatment as Usual | Other | Continuation of current ADHD treatment |
|