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NCT02853032 · ClinicalTrials.gov registry record · NA
Image-guided, Robotically Delivered Transcranial Magnetic Stimulation Treatment for Combat-Related Post-Traumatic Stress Disorder
A NA study, sponsored by The University of Texas Health Science Center at San Antonio.
- Completed
- Registry status
- NA
- Development phase
- 119
- Enrollment target
NCT02853032 is a NA study that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 119 participants.
The verdict
NCT02853032, a NA study, has completed, sponsored by The University of Texas Health Science Center at San Antonio.
- COMPLETED
- Registry status
- NA
- Development phase
- 119 participants
- Enrollment target
Study Summary
Mounting amounts of evidence suggests that non-invasive stimulation of the dorsolateral prefrontal cortex (DLPFC) using repetitive transcranial magnetic stimulation (rTMS) maybe a safe and effective treatment modality for Post-Traumatic Stress Disorder (PTSD). However the large variability in the magnitude of clinical outcomes reported is likely related to the current lack of knowledge of ideal side of stimulation (left vs right) and the limited precision in the targeting of brain circuits needed to obtain an optimal treatment response. In this protocol the investigators will: 1) generate individualized treatment plans based on an individual's functional Magnetic Resonance Imaging (fMRI) and meta-analytical based connectivity analysis to guide the delivery of adjunct, imaging-based \& robotically delivered rTMS to active duty military (ADM) subjects with PTSD participating in an intensive program providing integrated evidence-based psychotherapy and pharmacological management (Treatment as Usual (TAU)). 2) To use clinician ratings and self-report PTSD symptom scales, as well as other indicators of clinical change, to determine whether compared with TAU, addition of adjunct rTMS improves clinical outcomes. 3) To conduct neuroimaging-based assessments aimed to measure rTMS effects on network connectivity in ADM receiving treatment for PTSD and the potential correlation of connectivity changes with clinical outcomes.
Interventions
- DEVICE Sham repetitive transcranial magnetic stimulation
- DEVICE Active repetitive transcranial magnetic stimulation
- DEVICE robotic arm
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 119 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2019-03-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02853032
The ClinicalTrials.gov registry entry for NCT02853032 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 119 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center at San Antonio, which has 378 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Sham repetitive transcranial magnetic stimulation is the first listed.
NCT02853032 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02853032 about?
NCT02853032 is a clinical study titled "Image-guided, Robotically Delivered Transcranial Magnetic Stimulation Treatment for Combat-Related Post-Traumatic Stress Disorder". Mounting amounts of evidence suggests that non-invasive stimulation of the dorsolateral prefrontal cortex (DLPFC) using repetitive transcranial magnetic stimulation (rTMS) maybe a safe and effective treatment modality for Post-Traumatic Stress Disorder (PTSD). However the large variability in the ma...
What is the current status of trial NCT02853032?
This trial is currently completed. It is a NA study. The enrollment target is 119 participants. The study started on 2017-07-05. Estimated completion is 2019-03-25.
What interventions are being tested in trial NCT02853032?
The interventions under investigation include: Sham repetitive transcranial magnetic stimulation (DEVICE), Active repetitive transcranial magnetic stimulation (DEVICE), robotic arm (DEVICE).
Who is sponsoring clinical trial NCT02853032?
This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.
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