Efficacy of Neuro+ Attention Training

NCT ID: NCT02642055

Last Updated: 2016-12-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-10-31

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.

Conditions

ADHD

Keywords

ADHD; Neurofeedback; Biofeedback; Neuro+; Go/no-go; Attention training

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Neuro+ Intervention

30 sessions (900 minutes) of Neuro+ Attention Training administered over 10 weeks.

Group Type: EXPERIMENTAL

Neuro+ Attention Training

Intervention Type: BEHAVIORAL

Attention training program with Neuro+ software

Treatment as Usual

Continuation of current treatment for ADHD

Group Type: ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type: OTHER

Continuation of current ADHD treatment

Interventions

Neuro+ Attention Training

Attention training program with Neuro+ software

Intervention Type: BEHAVIORAL

Treatment as Usual

Continuation of current ADHD treatment

Intervention Type: OTHER

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuro+

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandeep Vaishnavi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Carolina Partners in Mental HealthCare, PLLC

Locations

Neuropsychiatric Clinic at Carolina Partners in Mental HealthCare

Raleigh, North Carolina, United States

Countries

United States

Other Identifiers

NEURO+001

Identifier Type: -

Identifier Source: org_study_id