Recruiting

NeuroTrainer

Sponsor:

NeuroTrainer

Code:

NCT06512974

Conditions

ADHD - Combined Type

ADHD Predominantly Inattentive Type

ADHD, Predominantly Hyperactive - Impulsive

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Accepted

Interventions

NeuroTrainer

Study Details

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

Study ID

NCT06512974

Start date

Sep 1, 2024

Status verified date

Jun, 2025

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Feb 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 17

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

155 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NeuroTrainer Intervention

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.

no intervention: Control Condition

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

Virtual reality based cognitive training

Primary outcome measure

  • NIH Toolbox Flanker Inhibitory Control and Attention Test (RT) [ Time Frame: Week 1, Month 2, Month 3, Month 9 ]
  • NIH Toolbox Flanker Inhibitory Control and Attention Test (IIV-RT) [ Time Frame: Week 1, Month 2, Month 3, Month 9 ]
  • NIH Toolbox Flanker Inhibitory Control and Attention Test (% Correct) [ Time Frame: Week 1, Month 2, Month 3, Month 9 ]
  • NIH Toolbox Dimensional Change Card Sort Test (% Correct) [ Time Frame: Week 1, Month 2, Month 3, Month 9 ]
  • NIH Toolbox Dimensional Change Card Sort Test (Omissions) [ Time Frame: Week 1, Month 2, Month 3, Month 9 ]
  • NIH Toolbox Dimensional Change Card Sort Test (RT) [ Time Frame: Week 1, Month 2, Month 3, Month 9 ]
  • NIH Toolbox Dimensional Change Card Sort Test (IIV-RT) [ Time Frame: Week 1, Month 2, Month 3, Month 9 ]
  • NIH Toolbox List Sorting Working Memory Test [ Time Frame: Week 1, Month 2, Month 3, Month 9 ]
  • NIH Toolbox Pattern Comparison Processing Speed Test [ Time Frame: Week 1, Month 2, Month 3, Month 9 ]

Central Contacts and Locations

Central contacts

Julie Schweitzer, Ph.D.

Jschweitzer@ucdavis.edu

Locations

Marquette Senior High School

Recruiting

Marquette, Michigan, United States, 49855

Contacts

Principal Investigator:

Jeff Nyquist, Ph.D.

Westside High School

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

One City Schools

Recruiting

Madison, Wisconsin, United States, 53713

Contacts

More Information

Sponsor

NeuroTrainer

Last update posted

Jun 19, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by NeuroTrainer on 2025-06-19.