Clinical trial NCT06512974: NeuroTrainer Cognitive Training For Academic Focus
Official title: A Feasibility and Efficacy Study of NeuroTrainer Cognitive Training in Students With and Without Attention-Related Difficulties
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ADHD - Combined Type
ADHD Predominantly Inattentive Type
ADHD, Predominantly Hyperactive - Impulsive
Lead sponsor: NeuroTrainer
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of California, Davis
First posted: 2024-07-22
Enrollment: 155
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: NIH Toolbox Flanker Inhibitory Control and Attention Test (RT)
timeFrame: Week 1, Month 2, Month 3, Month 9
measure: NIH Toolbox Flanker Inhibitory Control and Attention Test (IIV-RT)
timeFrame: Week 1, Month 2, Month 3, Month 9
measure: NIH Toolbox Flanker Inhibitory Control and Attention Test (% Correct)
timeFrame: Week 1, Month 2, Month 3, Month 9
measure: NIH Toolbox Dimensional Change Card Sort Test (% Correct)
timeFrame: Week 1, Month 2, Month 3, Month 9
measure: NIH Toolbox Dimensional Change Card Sort Test (Omissions)
timeFrame: Week 1, Month 2, Month 3, Month 9
measure: NIH Toolbox Dimensional Change Card Sort Test (RT)
timeFrame: Week 1, Month 2, Month 3, Month 9
measure: NIH Toolbox Dimensional Change Card Sort Test (IIV-RT)
timeFrame: Week 1, Month 2, Month 3, Month 9
measure: NIH Toolbox List Sorting Working Memory Test
timeFrame: Week 1, Month 2, Month 3, Month 9
measure: NIH Toolbox Pattern Comparison Processing Speed Test
timeFrame: Week 1, Month 2, Month 3, Month 9
Secondary outcomes:
measure: ADHD Rating Scale-5 (ADHD:RS-5) - Inattention Subscale
timeFrame: Week 1, Month 2, Month 3, Month 9
measure: ADHD Rating Scale-5 (ADHD:RS-5) - Impulsivity/Hyperactivity Subscale
timeFrame: Week 1, Month 2, Month 3, Month 9
measure: Academic Performance Rating Scale (APRS)
timeFrame: Week 1, Month 2, Month 3, Month 9
Other outcomes:
Locations:
Study officials:
affiliation: NeuroTrainer
name: Jeff Nyquist, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: