Efficacy of Neuro+ Attention Training

ADHD Clinical Trial

Official title:

Efficacy of NEURO+ Attention Training: A Randomized, Controlled, Blinded, Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642055
• Other study ID #: NEURO+001
• Status: Completed
• Phase: N/A
• First received: December 18, 2015
• Last updated: December 20, 2016
• Start date: December 2015
• Est. completion date: October 2016

Study information

• Verified date: May 2016
• Source: Neuro+
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 13 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• Neuro+ Attention Training
Attention training program with Neuro+ software

Other:
• Treatment as Usual
Continuation of current ADHD treatment

Locations

Country	Name	City	State
United States	Neuropsychiatric Clinic at Carolina Partners in Mental HealthCare	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Neuro+

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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.	Yes
Secondary	Self-reported convenience ratings of Neuro+ intervention	As evaluated on a Likert scale, the extent to which subjects and parents found the Neuro+ intervention convenient/easy-to-use	At final clinical visit, within 1 week following intervention	No