Efficacy of Neuro+ Attention Training

NCT02642055 | Completed

• 1 other identifier: NEURO+001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

Secondary Outcomes (1)

• Self-reported convenience ratings of Neuro+ intervention

  At final clinical visit, within 1 week following intervention

Study Arms (2)

Neuro+ Intervention

EXPERIMENTAL

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

Behavioral: Neuro+ Attention Training

Treatment as Usual

ACTIVE COMPARATOR

Continuation of current treatment for ADHD

Other: Treatment as Usual

Interventions

Neuro+ Attention Training BEHAVIORAL

Attention training program with Neuro+ software

Neuro+ Intervention

Treatment as Usual OTHER

Continuation of current ADHD treatment

Treatment as Usual

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neuro+: lead

Study Sites (1)

Neuropsychiatric Clinic at Carolina Partners in Mental HealthCare

Raleigh, North Carolina, 27609, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Sandeep Vaishnavi, MD, PhD

  Carolina Partners in Mental HealthCare, PLLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2015
• First Posted: December 30, 2015
• Study Start: December 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 21, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)