NeuroTrainer Cognitive Training For Academic Focus

NCT06512974 | Recruiting DMC

• 1 other identifier: 1R43MH135599-01A1
• Study Type: interventional
• Target: 155
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical trial aims to evaluate the feasibility and efficacy of NeuroTrainer cognitive training in improving attentional and executive control functions in students with and without attention-related difficulties.

Conditions

ADHD - Combined Type; ADHD Predominantly Inattentive Type; ADHD, Predominantly Hyperactive - Impulsive

Outcome Measures

Primary Outcomes (9)

• NIH Toolbox Flanker Inhibitory Control and Attention Test (RT)

  This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the reaction time (RT) outcome from this assessment.

  Week 1, Month 2, Month 3, Month 9

• NIH Toolbox Flanker Inhibitory Control and Attention Test (IIV-RT)

  This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the intraindividual variability of RT (IIV-RT) outcome from this assessment.

  Week 1, Month 2, Month 3, Month 9

• NIH Toolbox Flanker Inhibitory Control and Attention Test (% Correct)

  This test is designed to evaluate an individual's ability to concentrate their attention while inhibiting automatic response tendencies that could potentially hinder goal achievement. The assessment has demonstrated changes in ADHD cases (Buzy, et al., 2009) and may be sensitive to treatment effects (Epstein et al., 2011). The test will take approximately 3 minutes to complete. This is the percent correct outcome from this assessment.

  Week 1, Month 2, Month 3, Month 9

• NIH Toolbox Dimensional Change Card Sort Test (% Correct)

  This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the percent correct outcome from this assessment.

  Week 1, Month 2, Month 3, Month 9

• NIH Toolbox Dimensional Change Card Sort Test (Omissions)

  This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the omissions outcome from this assessment.

  Week 1, Month 2, Month 3, Month 9

• NIH Toolbox Dimensional Change Card Sort Test (RT)

  This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the response time (RT) outcome from this assessment.

  Week 1, Month 2, Month 3, Month 9

• NIH Toolbox Dimensional Change Card Sort Test (IIV-RT)

  This test aims to measure an individual's capacity to switch between multiple aspects of a strategy or task. The test takes approximately 4 minutes to complete. This is the intraindividual variability of RT (IIV-RT) outcome from this assessment.

  Week 1, Month 2, Month 3, Month 9

• NIH Toolbox List Sorting Working Memory Test

  This test serves as an evaluation of an individual's working memory capabilities. Participants will be presented with different stimuli visually and audibly, and they will be asked to recall and sequence them accordingly. The test takes approximately 7 minutes to complete.

  Week 1, Month 2, Month 3, Month 9

• NIH Toolbox Pattern Comparison Processing Speed Test

  This is an assessment of processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same. The test takes approximately 4 minutes to complete.

  Week 1, Month 2, Month 3, Month 9

Secondary Outcomes (3)

• ADHD Rating Scale-5 (ADHD:RS-5) - Inattention Subscale

  Week 1, Month 2, Month 3, Month 9

• ADHD Rating Scale-5 (ADHD:RS-5) - Impulsivity/Hyperactivity Subscale

  Week 1, Month 2, Month 3, Month 9

• Academic Performance Rating Scale (APRS)

  Week 1, Month 2, Month 3, Month 9

Study Arms (2)

NeuroTrainer Intervention

EXPERIMENTAL

The NeuroTrainer intervention involves using a VR-based cognitive training program designed to improve attention and executive function in students with ADHD. Participants will engage in 30-minute sessions, approximately three times a week for 12 weeks, performing game-like tasks that integrate physical activity and adapt to their performance level.

Behavioral: NeuroTrainer

Control Condition

NO INTERVENTION

The control condition involves students receiving standard educational interventions without the use of NeuroTrainer. These activities include regular classroom instruction and typical academic tasks designed to support learning, without the additional cognitive training provided by the VR program.

Interventions

NeuroTrainer BEHAVIORAL

Virtual reality based cognitive training

NeuroTrainer Intervention

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Diagnostic criteria met ADHD for any ADHD presentation type, with severity ratings of subthreshold, moderate or severe
• Estimated IQ of 80 or greater
• Between 11-17 years of age

You may not qualify if:

• Presence of suicidality
• Presence of psychotic disorders
• Visual or hearing impairment
• Presence of severe depression

Sponsors & Collaborators

• NeuroTrainer: lead
• National Institute of Mental Health (NIMH): collaborator
• University of California, Davis: collaborator

Study Sites (3)

Marquette Senior High School

Marquette, Michigan, 49855, United States

RECRUITING

Westside High School

Omaha, Nebraska, 68114, United States

RECRUITING

One City Schools

Madison, Wisconsin, 53713, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Jeff Nyquist, Ph.D.

  NeuroTrainer

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeff Nyquist, Ph.D.

CONTACT

9062507356; jnyquist@neurotrainer.com

Julie Schweitzer, Ph.D.

CONTACT

Jschweitzer@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Science Officer

Model Details: This study will evaluate the efficacy of NeuroTrainer cognitive training for improving attention and executive function in students with ADHD and sub threshold ADHD, divided into intervention and control groups. Participants, aged 11-17, will be randomly assigned to use NeuroTrainer or receive standard educational activity. Primary outcomes include attention and executive function improvements, while secondary outcomes assess ADHD symptoms and academic performance. Data will be collected at baseline, midpoint, post-intervention and 6-month follow-up.

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 22, 2024
• Study Start: September 1, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)