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NCT03746405 · ClinicalTrials.gov registry record · NA
Effects of Connectivity-based rTMS and State-Dependency on Amygdala Activation
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 25
- Enrollment target
NCT03746405: Completed NA study, sponsored by Duke University.
NCT03746405 is a NA study that has completed, run by Duke University. The registered enrollment target is 25 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03746405, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
Study Summary
Posttraumatic stress disorder (PTSD) is a highly debilitating disease with response rates to pharmacological treatment rarely exceeding 60%. Preliminary attempts have been made to use repetitive transcranial magnetic stimulation (rTMS) as a non-pharmacological treatment alternative, but thus far rTMS approaches have demonstrated only modest efficacy. A major factor contributing to these limited effects stems from the depth penetration of TMS, which is not sufficient to directly modulate deep subcortical structures, such as the amygdala, that are affected in PTSD. Moreover, while rTMS effects have been shown to be state-dependent, (i.e. vary substantially according to the neural state during stimulation), this important factor is rarely considered during the clinical application of rTMS. The current study addresses both of these limitations to improve the therapeutic efficacy of rTMS for PTSD. Here we will develop a protocol to test if connectivity-based rTMS is able to modulate amygdala activity through the functional connections with medial prefrontal cortex, taking advantage of state-dependency to enhance rTMS effects by actively engaging the amygdala through a fear perception task. BOLD activation in the amygdala and its connectivity with the frontal cortex will constitute the primary outcomes to test rTMS efficacy. Heart rate variability and skin galvanic responses, acquired during the presentation of fearful faces, will be used as continuous moderators of task engagement during rTMS. If successful, this study will pave the way for a large-scale study to investigate whether state-dependent, connectivity-based rTMS of the amygdala can improve rTMS efficacy as a clinical treatment for PTSD.
Primary Outcome
Blood oxygenation level dependent (BOLD) will be assessed to evaluate the acute effect of rTMS applied over the medial prefrontal cortex on the amygdala activation. This outcome (expressed a z-score) represents the amygdala activation, either after active rTMS or after sham rTMS. Higher z-scores for active than for sham rTMS indicates that amygdala activity increases after active rTMS compared to sham rTMS, on the other hand lower z-score after active rTMS vs. after Sham rTMS indicated that th
Interventions
- DEVICE repetitive transcranial magnetic stimulation
- DEVICE Sham repetitive transcranial magnetic stimulation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-06-16 |
| Est. Completion | 2020-01-31 |
| Phase | NA |
What the finished NCT03746405 record still lists
NCT03746405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which repetitive transcranial magnetic stimulation is the first listed.
NCT03746405 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03746405 about?
NCT03746405 is a clinical study titled "Effects of Connectivity-based rTMS and State-Dependency on Amygdala Activation". Posttraumatic stress disorder (PTSD) is a highly debilitating disease with response rates to pharmacological treatment rarely exceeding 60%. Preliminary attempts have been made to use repetitive transcranial magnetic stimulation (rTMS) as a non-pharmacological treatment alternative, but thus far rTM...
What is the current status of trial NCT03746405?
This trial is currently completed. It is a NA study. The enrollment target is 25 participants. The study started on 2019-06-16. Estimated completion is 2020-01-31.
What interventions are being tested in trial NCT03746405?
The interventions under investigation include: repetitive transcranial magnetic stimulation (DEVICE), Sham repetitive transcranial magnetic stimulation (DEVICE).
Who is sponsoring clinical trial NCT03746405?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03746405's enrollment target sits among peer trials
25 1712th of 2000 higher than 265 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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