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Individualized (fMRI-guided) TMS Intervention for Post-Traumatic Stress Disorder (PTSD)

NCT07785908 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-31

No results posted yet for this study

Summary

The goal of this clinical trial is to learn how transcranial magnetic stimulation (TMS) affects brain circuits involving the amygdala in adults with posttraumatic stress disorder (PTSD). The main questions it aims to answer are:

* Can MRI-guided TMS engage the amygdala by stimulating an individualized brain target connected to the amygdala?
* Does stimulation of this individualized target engage the amygdala differently than stimulation of control sites?
* Does a 6-week course of active TMS, compared with sham TMS, change amygdala responses and physiological responses to fear?

Researchers will compare active TMS with sham TMS to evaluate changes in the targeted brain circuit and fear-related responses.

Participants will:

* Receive active or sham TMS every weekday for 6 weeks
* Undergo MRI scans with TMS before and after the 6-week intervention to measure brain responses to stimulation
* Participate in fear learning and memory tasks while physiological responses are measured
* Undergo additional MRI scans, clinical assessments, questionnaires, and cognitive testing
* Complete remote follow-up assessments at 1, 6, and 12 months after the intervention

Conditions

  • PTSD
  • Post Traumatic Stress Disorder (PTSD)

Interventions

DEVICE

Active Transcranial Magnetic Stimulation (TMS)

The TMS intervention will involve two sets of intermittent theta-burst stimulation (iTBS) delivered every weekday for 6 weeks (30 sessions). Each iTBS set consists of 40 trains and 1,200 pulses, for a total of 2,400 pulses per treatment session. The two iTBS sets will be separated by approximately 5 minutes and delivered to the individualized amygdala-connected cortical target using MRI-guided neuronavigation.

DEVICE

Sham Transcranial Magnetic Stimulation (TMS)

The sham TMS intervention will follow the same treatment schedule and session structure as active TMS. Sham stimulation will be delivered using the shielded side of the TMS coil together with synchronized scalp electrical stimulation to mimic the sensation of active TMS without delivering the intended magnetic stimulation to the targeted brain region.

Sponsors & Collaborators

Principal Investigators

  • Desmond Oathes, PhD · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-12
Primary Completion
2028-06-30
Completion
2028-08-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07785908 on ClinicalTrials.gov