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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: Clinical Trial NA study, sponsored by Henry M. Jackson Foundation for the Advancement of Military Medicine.

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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Compare change in overall Montgomery-Asberg Depression Rating Scale (MADRS) scores between participants randomized to ICT-rTMS and those randomized to blinded sham stimulation. The overall score ranges from 0 to 60 with a higher overall score indicating more severe depression.

Interventions

  • DEVICE Active: rTMS
  • DEVICE Sham: rTMS

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2019-07-01
Est. Completion 2020-10-27
Phase NA

Why NCT03523507 stopped before completion

NCT03523507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Active: rTMS is the first listed.

NCT03523507 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT03523507's enrollment target sits among peer trials

10 1927th of 2000 higher than 26 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT03523507, the US trial registry maintained by the National Library of Medicine. NCT03523507 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.