Efficacy of Neuro+ Attention Training
| Status: | Completed |
|---|---|
| Conditions: | Psychiatric, ADHD |
| Therapuetic Areas: | Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 8 - 13 |
| Updated: | 12/22/2016 |
| Start Date: | December 2015 |
| End Date: | October 2016 |
Efficacy of NEURO+ Attention Training: A Randomized, Controlled, Blinded, Clinical Trial
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.
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.
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.
Inclusion Criteria:
- Age 8 to 13 at the time of parental informed consent.
- Confirmed ADHD diagnosis at clinic
- No usage of ADHD drugs in past 30 days, or stable on current drug regimen for at
least 30 days. Drugs include: Pre specified, oral psychostimulants, including
ADDERALL XR® [mixed salts of a single-entity amphetamine product], VYVANSE®
[lisdexamfetamine dimesylate], CONCERTA® [methylphenidate HCl], FOCALIN XR®
[dexmethylphenidate HCl], RITALIN LA® [methylphenidate HCl extended-release],
METADATE CD® [methylphenidate HCl, USP], or other FDA-approved equivalents.
- Ability to follow written and verbal instructions (English)
- Girls or Boys
- Functioning at an age-appropriate level intellectually.
- Ability to comply with all the testing and requirements.
Exclusion Criteria:
- Current, controlled (requiring a restricted medication) or uncontrolled, comorbid
psychiatric diagnosis with significant symptoms such as post-traumatic stress
disorder, psychosis, bipolar illness, pervasive developmental disorder, severe
obsessive compulsive disorder, severe depressive or severe anxiety disorder, conduct
disorder, or other symptomatic manifestations that in the opinion of the Investigator
that may confound study data/assessments.
- Motor condition that prevents game playing.
- Recent history (within the past 6 months) of suspected substance abuse or dependence.
- History of seizures (exclusive of febrile seizures), a tic disorder, significant
tics, or a current diagnosis of Tourette's Disorder.
- Taken part in a clinical trial within 30 days prior to screening.
- Diagnosis of color blindness.
- Regular use of psychoactive drugs that in the opinion of the Investigator may
confound study data/assessments.
- Any other medical condition that in the opinion of the Investigator may confound
study data/assessments.
We found this trial at
1
site
Raleigh, North Carolina 27609
Principal Investigator: Sandeep Vaishnavi, MD, PhD
Phone: 919-792-3940
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