NeuroTrainer Cognitive Training For Academic Focus

NCT ID: NCT06512974

Last Updated: 2025-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

155 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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The goal of this clinical trial is to test the feasibility and efficacy of NeuroTrainer cognitive training in improving attentional and executive control function in students with and without attention-related difficulties. The main questions it aims to answer are (1) does NeuroTrainer improve attentional and executive control function, (2) does NeuroTrainer engage the target of ADHD inattention symptoms by identifying the target and demonstrating proximal changes in it, and (3) does NeuroTrainer demonstrate transfer of skill with improvement in academic behaviors. Researchers will compare students who use NeuroTrainer to a control condition to see if the NeuroTrainer intervention produces significant improvements.

Participants in the intervention group will engage in virtual reality (VR) sessions which include physical activity and cognitive training. Cognitive training will maximize time at performance thresholds and optimize for variability in task dynamics and demands.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

NeuroTrainer

Intervention Type BEHAVIORAL

Virtual reality based cognitive training

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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NeuroTrainer

Virtual reality based cognitive training

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

11 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of California, Davis

OTHER

Sponsor Role collaborator

NeuroTrainer

INDUSTRY

Sponsor Role lead

Responsible Party

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Jeff Nyquist

Chief Science Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeff Nyquist, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

NeuroTrainer

Locations

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Marquette Senior High School

Marquette, Michigan, United States

Site Status RECRUITING

Westside High School

Omaha, Nebraska, United States

Site Status RECRUITING

One City Schools

Madison, Wisconsin, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jeff Nyquist, Ph.D.

Role: CONTACT

9062507356

Julie Schweitzer, Ph.D.

Role: CONTACT

Facility Contacts

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Brandon Wheeler

Role: primary

906-225-5353

Jay Dostal, Ed.D.

Role: primary

402-343-2600

Jeremy Clements

Role: primary

608-790-2829

Other Identifiers

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1R43MH135599-01A1

Identifier Type: NIH

Identifier Source: org_study_id

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