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Efficacy of Neuro+ Attention Training

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02642055
Recruitment Status : Completed
First Posted : December 30, 2015
Last Update Posted : December 21, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
ADHD Behavioral: Neuro+ Attention Training Other: Treatment as Usual Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of NEURO+ Attention Training: A Randomized, Controlled, Blinded, Clinical Trial
Study Start Date : December 2015
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Arm Intervention/treatment
Experimental: Neuro+ Intervention
30 sessions (900 minutes) of Neuro+ Attention Training administered over 10 weeks.
Behavioral: Neuro+ Attention Training
Attention training program with Neuro+ software

Active Comparator: Treatment as Usual
Continuation of current treatment for ADHD
Other: Treatment as Usual
Continuation of current ADHD treatment

Primary Outcome Measures :
  1. Change in ADHD symptoms with Quotient ADHD System assessment [ Time Frame: At screening and at final clinical visit within 1 week following intervention ]
    Assessments to be conducted with the Quotient ADHD System

  2. Change in assessment of ADHD symptoms with Conners 3-Parent rating scale [ Time Frame: At screening and at final clinical visit within 1 week following intervention ]
    Assessments to be conducted with the Conners 3-Parent rating scale

  3. Incidence of adverse events [ Time Frame: As reported by subjects at final clinical visit, which occurs within 1 week following intervention. ]
    Self-reported incidence of adverse events

Secondary Outcome Measures :
  1. Self-reported convenience ratings of Neuro+ intervention [ Time Frame: At final clinical visit, within 1 week following intervention ]
    As evaluated on a Likert scale, the extent to which subjects and parents found the Neuro+ intervention convenient/easy-to-use

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   8 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02642055

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United States, North Carolina
Neuropsychiatric Clinic at Carolina Partners in Mental HealthCare
Raleigh, North Carolina, United States, 27609
Sponsors and Collaborators
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Principal Investigator: Sandeep Vaishnavi, MD, PhD Carolina Partners in Mental HealthCare, PLLC
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Responsible Party: Neuro+ Identifier: NCT02642055    
Other Study ID Numbers: NEURO+001
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Neuro+:
Attention training