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Recruiting NCT06512974

NeuroTrainer Cognitive Training For Academic Focus

No phase Interventional ADHD - Combined Type ADHD Predominantly Inattentive Type ADHD, Predominantly Hyperactive - Impulsive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NeuroTrainer.
Who it may be relevant to
Registry conditions: ADHD - Combined Type, ADHD Predominantly Inattentive Type, ADHD, Predominantly Hyperactive - Impulsive. Basic parameters: 11 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Feasibility and Efficacy Study of NeuroTrainer Cognitive Training in Students With and Without Attention-Related Difficulties

Overview

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

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.

Interventions

  • Behavioral NeuroTrainer
    Virtual reality based cognitive training

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • ADHD Rating Scale-5 (ADHD:RS-5) - Inattention Subscale [Time frame: Week 1, Month 2, Month 3, Month 9]
  • ADHD Rating Scale-5 (ADHD:RS-5) - Impulsivity/Hyperactivity Subscale [Time frame: Week 1, Month 2, Month 3, Month 9]
  • Academic Performance Rating Scale (APRS) [Time frame: Week 1, Month 2, Month 3, Month 9]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Marquette Senior High School — Marquette
  • Westside High School — Omaha
  • One City Schools — Madison

Identifiers

NCT: NCT06512974 · 1R43MH135599-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗