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NCT06413173 · ClinicalTrials.gov registry record · NA
Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)
A NA study of Mild Cognitive Impairment and Mild Traumatic Brain Injury, sponsored by United States Naval Medical Center, San Diego.
- Recruiting
- Registry status
- NA
- Development phase
- 160
- Enrollment target
- 2
- Study locations
NCT06413173: Recruiting NA study of Mild Cognitive Impairment and Mild Traumatic Brain Injury, sponsored by United States Naval Medical Center, San Diego.
NCT06413173 is a NA study of Mild Cognitive Impairment and Mild Traumatic Brain Injury that is actively recruiting participants, run by United States Naval Medical Center, San Diego. The registered enrollment target is 160 participants, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (87% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06413173, a NA study of Mild Cognitive Impairment and Mild Traumatic Brain Injury, is actively recruiting participants, sponsored by United States Naval Medical Center, San Diego.
- RECRUITING
- Registry status
- NA
- Development phase
- 160 participants
- Enrollment target
- 2
- Study locations
Study Summary
The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both healthy and clinical populations. RS-tDCS+ is a home-based, low-risk, non-invasive technique that is designed to boost cognitive training by enhancing learning and the brain's ability to reorganize connections. This study will evaluate RS-tDCS+ for improving complex attention in Active Duty Service Members (ADSM) and Veterans with a history of mTBI. Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham (placebo) RS-tDCS+. Second, the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS+ using electroencephalogram (EEG) and magnetic resonance imaging (MRI). Third, the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment. Lastly, the investigators will explore the impact of individual differences (e.g., PTSD, depression, sleep quality, time since injury, baseline impairment, age, sex, ADSM versus Veteran) on treatment outcome.
Primary Outcome
Standardized neuropsychological assessment measure of visual attention and working memory
Conditions Studied
Interventions
- COMBINATION_PRODUCT Active tDCS and Cognitive Training Intervention
- COMBINATION_PRODUCT Sham tDCS and Cognitive Training Intervention
Study Locations (2)
California
- Naval Medical Center San Diego - San Diego
Minnesota
- Minneapolis VA Health Case System - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2024-07-25 |
| Est. Completion | 2028-09-30 |
| Phase | NA |
What NCT06413173 shows while recruiting
NCT06413173 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 1,270-participant average among 205 other Mild Cognitive Impairment trials with a reported enrollment target (87% lower).
The record links to 10 conditions, with Mild Cognitive Impairment appearing as the primary indexed condition, and to 2 interventions - of which Active tDCS and Cognitive Training Intervention is the first listed.
NCT06413173 reports a single indexed study location in California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06413173 about?
NCT06413173 is a clinical study titled "Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric)". The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called "Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training" (RS-tDCS+) which has shown promise for improving complex attention in both hea...
What is the current status of trial NCT06413173?
This trial is currently recruiting. It is a NA study. The enrollment target is 160 participants. The study started on 2024-07-25. Estimated completion is 2028-09-30.
What conditions does trial NCT06413173 study?
This clinical trial studies the following conditions: Mild Cognitive Impairment, Mild Traumatic Brain Injury, Brain Injuries, Brain Injuries, Traumatic, Memory Impairment.
What interventions are being tested in trial NCT06413173?
The interventions under investigation include: Active tDCS and Cognitive Training Intervention (COMBINATION_PRODUCT), Sham tDCS and Cognitive Training Intervention (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06413173?
This trial is sponsored by United States Naval Medical Center, San Diego, which has 41 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06413173 being conducted?
This trial has 2 study locations across California, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06413173's enrollment target sits among peer trials
160 62nd of 205 higher than 144 of 205 other Mild Cognitive Impairment trials
participants (enrollment target), bucketed by value
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