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NCT03523507 · ClinicalTrials.gov registry record · NA
fMRI-neuronavigated rTMS Treatment for Symptoms of Depression Associated With Concussive TBI in the Military Population
A NA study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT03523507 is a NA study that was terminated before completion, run by Henry M. Jackson Foundation for the Advancement of Military Medicine. The registered enrollment target is 10 participants.
The verdict
NCT03523507, a NA study, was terminated before completion, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
This study aims to investigate the efficacy and tolerability of fMRI-targeted repetitive transcranial magnetic stimulation (rTMS) in the treatment of depressive symptoms in service members with a history of concussive traumatic brain injury (TBI). Up to ninety participants will be randomized to active or sham treatment. Participants randomized into the active group will receive 20 sessions of left-sided dorsolateral prefrontal cortex (DLFPC) high-frequency rTMS, followed by right-sided DLFPC low-frequency rTMS. The DLPFC treatment area will be identified by using individual subject-level resting state network estimation (Hacker et al., 2013). Participants randomized into the sham treatment group will receive 20 sham treatments designed to have similar sound and tactile sensation, without producing active treatment. Participants will also be asked to complete regular follow-up evaluations for up to a total of six follow-up sessions. Those who do not respond to the treatment will have the option to receive active treatment through this study regardless of group assignment to active or sham.
Interventions
- DEVICE Active: rTMS
- DEVICE Sham: rTMS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-07-01 |
| Est. Completion | 2020-10-27 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03523507
The ClinicalTrials.gov registry entry for NCT03523507 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Active: rTMS is the first listed.
NCT03523507 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03523507 about?
NCT03523507 is a clinical study titled "fMRI-neuronavigated rTMS Treatment for Symptoms of Depression Associated With Concussive TBI in the Military Population". This study aims to investigate the efficacy and tolerability of fMRI-targeted repetitive transcranial magnetic stimulation (rTMS) in the treatment of depressive symptoms in service members with a history of concussive traumatic brain injury (TBI). Up to ninety participants will be randomized to act...
What is the current status of trial NCT03523507?
This trial is currently terminated. It is a NA study. The enrollment target is 10 participants. The study started on 2019-07-01. Estimated completion is 2020-10-27.
What interventions are being tested in trial NCT03523507?
The interventions under investigation include: Active: rTMS (DEVICE), Sham: rTMS (DEVICE).
Who is sponsoring clinical trial NCT03523507?
This trial is sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine, which has 60 total clinical trials registered on ClinicalTrials.gov.
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