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NCT04109027 · ClinicalTrials.gov registry record · NA
Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond
A NA study of Cognitive Dysfunction and TBI, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT04109027: Recruiting NA study of Cognitive Dysfunction and TBI, sponsored by VA Office of Research and Development.
NCT04109027 is a NA study of Cognitive Dysfunction and TBI that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 120 participants, below the 1,990-participant average among 45 other Cognitive Dysfunction trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04109027, a NA study of Cognitive Dysfunction and TBI, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
For many Veterans, success in achieving goals at work, school and in other aspects of life are top priorities. The abilities to regulate attention, remember key information, and stay calm and on track are fundamental to this success. Unfortunately, Veterans who have experienced a traumatic brain injury (TBI) often struggle with these very abilities, and a number of barriers can make it difficult for them to access the help Veterans need. Tele-rehabilitation has the potential to overcome some of these barriers and increase access to care, enabling providers to better reach Veterans 'where they are' in their communities. This project will assess two different approaches to brain injury rehabilitation that seek to help Veterans build personal strengths to better accomplish their goals. Both approaches will be delivered remotely via tele-rehabilitation and augmented by digital apps to best support Veterans' learning in community settings outside the VA.
Primary Outcome
In order to test a primary hypothesis related to potential intervention mechanisms, the investigators will use the well-established Automated Operation Span Task (OSPAN) to measure working memory in the presence of distractions. Specifically, the OSPAN sums correctly recalled and ordered items from a memory set in the presence of distractors. The investigators elected to use this psychometric measure due to its sensitivity, precision, and test-retest stability in order to maximize the ability to
Conditions Studied
Interventions
- BEHAVIORAL BrainStrong-GSR
- BEHAVIORAL BrainStrong-OPT
Study Locations (1)
California
- VA Northern California Health Care System, Mather, CA - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-06-10 |
| Est. Completion | 2026-05-25 |
| Phase | NA |
What NCT04109027 shows while recruiting
NCT04109027 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 1,990-participant average among 45 other Cognitive Dysfunction trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Cognitive Dysfunction appearing as the primary indexed condition, and to 2 interventions - of which BrainStrong-GSR is the first listed.
NCT04109027 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04109027 about?
NCT04109027 is a clinical study titled "Strengthening Neuro-Cognitive Skills for Success in School, Work and Beyond". For many Veterans, success in achieving goals at work, school and in other aspects of life are top priorities. The abilities to regulate attention, remember key information, and stay calm and on track are fundamental to this success. Unfortunately, Veterans who have experienced a traumatic brain inj...
What is the current status of trial NCT04109027?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2024-06-10. Estimated completion is 2026-05-25.
What conditions does trial NCT04109027 study?
This clinical trial studies the following conditions: Cognitive Dysfunction, TBI.
What interventions are being tested in trial NCT04109027?
The interventions under investigation include: BrainStrong-GSR (BEHAVIORAL), BrainStrong-OPT (BEHAVIORAL).
Who is sponsoring clinical trial NCT04109027?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04109027 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04109027's enrollment target sits among peer trials
120 20th of 45 higher than 25 of 45 other Cognitive Dysfunction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cognitive Dysfunction trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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