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NCT02152540 · ClinicalTrials.gov registry record · NA
rTMS to Improve Cognitive Function in TBI
A NA study of Traumatic Brain Injury, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
- 1
- Study location
NCT02152540: Completed NA study of Traumatic Brain Injury, sponsored by VA Office of Research and Development.
NCT02152540 is a NA study of Traumatic Brain Injury that has completed, run by VA Office of Research and Development. The registered enrollment target is 33 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02152540, a NA study of Traumatic Brain Injury, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
- 1
- Study location
Study Summary
This project will study 40 Veterans identified with symptoms understood to characterize mild to moderate Traumatic Brain Injury (TBI) including Post Traumatic Stress Disorder (PTSD). Following screening and informed consent, Veterans will be randomly assigned to treatment with repetitive Transcranial Magnetic Stimulation (rTMS) or sham rTMS (placebo). Additional examinations will compare brain imaging (structural and functional MRI scans at rest) across participants at baseline, after acute rTMS treatment, and at 6 month followup. The VA population differs significantly from populations that have been included in prior trials of rTMS for many conditions such as depression, chronic pain, and PTSD. Many returning Operation Enduring Freedom (OEF)/Operation Iraqi Freedom (OIF) personnel and Veterans with concussion histories report cognitive problems, such as impaired attention, verbal fluency, poor planning, reduced working memory, and mental flexibility. The investigators hope to show the efficacy and durability of rTMS in treating these symptoms safely in Veterans with co-morbidities.
Primary Outcome
The primary hypothesis is that Veterans receiving active rTMS will show improvement more than sham treated Veterans in performance between baseline and last assessment of \>1 SD on the Trail Making Test part B. This test is known for its accurate assessment of executive function in mild and moderate TBI. The TMT is a timed test and the goal is to complete the test as accurately and as quickly as possible. Raw scores are reported in seconds to complete the test. For Part B, an average score is 7
Conditions Studied
Interventions
- DEVICE Sham rTMS
- DEVICE rTMS
Study Locations (1)
California
- VA Palo Alto Health Care System, Palo Alto, CA - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2014-10-01 |
| Est. Completion | 2019-06-30 |
| Phase | NA |
What the finished NCT02152540 record still lists
NCT02152540 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Sham rTMS is the first listed.
NCT02152540 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02152540 about?
NCT02152540 is a clinical study titled "rTMS to Improve Cognitive Function in TBI". This project will study 40 Veterans identified with symptoms understood to characterize mild to moderate Traumatic Brain Injury (TBI) including Post Traumatic Stress Disorder (PTSD). Following screening and informed consent, Veterans will be randomly assigned to treatment with repetitive Transcrania...
What is the current status of trial NCT02152540?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2014-10-01. Estimated completion is 2019-06-30.
What conditions does trial NCT02152540 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT02152540?
The interventions under investigation include: Sham rTMS (DEVICE), rTMS (DEVICE).
Who is sponsoring clinical trial NCT02152540?
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 NCT02152540 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
Similar trials for Traumatic Brain Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02152540's enrollment target sits among peer trials
33 137th of 171 higher than 34 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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