Efficacy of Neuro+ Attention Training
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|ClinicalTrials.gov Identifier: NCT02642055|
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : December 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|ADHD||Behavioral: Neuro+ Attention Training Other: Treatment as Usual||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of NEURO+ Attention Training: A Randomized, Controlled, Blinded, Clinical Trial|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
Experimental: Neuro+ Intervention
30 sessions (900 minutes) of Neuro+ Attention Training administered over 10 weeks.
Behavioral: Neuro+ Attention Training
Attention training program with Neuro+ software
Active Comparator: Treatment as Usual
Continuation of current treatment for ADHD
Other: Treatment as Usual
Continuation of current ADHD treatment
- Change in ADHD symptoms with Quotient ADHD System assessment [ Time Frame: At screening and at final clinical visit within 1 week following intervention ]Assessments to be conducted with the Quotient ADHD System
- Change in assessment of ADHD symptoms with Conners 3-Parent rating scale [ Time Frame: At screening and at final clinical visit within 1 week following intervention ]Assessments to be conducted with the Conners 3-Parent rating scale
- Incidence of adverse events [ Time Frame: As reported by subjects at final clinical visit, which occurs within 1 week following intervention. ]Self-reported incidence of adverse events
- Self-reported convenience ratings of Neuro+ intervention [ Time Frame: At final clinical visit, within 1 week following intervention ]As evaluated on a Likert scale, the extent to which subjects and parents found the Neuro+ intervention convenient/easy-to-use
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): NCT02642055
|United States, North Carolina|
|Neuropsychiatric Clinic at Carolina Partners in Mental HealthCare|
|Raleigh, North Carolina, United States, 27609|
|Principal Investigator:||Sandeep Vaishnavi, MD, PhD||Carolina Partners in Mental HealthCare, PLLC|