Clinical trial NCT02642055: Efficacy of Neuro+ Attention Training
Official title: Efficacy of NEURO+ Attention Training: A Randomized, Controlled, Blinded, Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: ADHD
Neurofeedback
Biofeedback
Neuro+
Go/no-go
Attention training
Lead sponsor: Neuro+
Sponsor class: INDUSTRY
First posted: 2015-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in ADHD symptoms with Quotient ADHD System assessment
timeFrame: At screening and at final clinical visit within 1 week following intervention
measure: Change in assessment of ADHD symptoms with Conners 3-Parent rating scale
timeFrame: At screening and at final clinical visit within 1 week following intervention
measure: Incidence of adverse events
timeFrame: As reported by subjects at final clinical visit, which occurs within 1 week following intervention.
Secondary outcomes:
measure: Self-reported convenience ratings of Neuro+ intervention
timeFrame: At final clinical visit, within 1 week following intervention
Other outcomes:
Locations:
city: Raleigh
country: United States
facility: Neuropsychiatric Clinic at Carolina Partners in Mental HealthCare
state: North Carolina
Study officials:
affiliation: Carolina Partners in Mental HealthCare, PLLC
name: Sandeep Vaishnavi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: