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

Sponsor
University of Pennsylvania
Study ID
NCT07785908
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • PTSD
  • Post Traumatic Stress Disorder (PTSD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Active Transcranial Magnetic Stimulation (TMS) — DEVICE
    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.
  • Sham Transcranial Magnetic Stimulation (TMS) — DEVICE
    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.

Study Details

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

Key Dates

First listed
Aug 25, 2026
Start date
Oct 12, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Active iTBS
    Participants will receive active intermittent theta burst stimulation (iTBS) delivered to an individualized ventrolateral prefrontal cortex (vlPFC) target selected based on positive resting-state functional connectivity with the basolateral amygdala. Active iTBS will be administered every weekday for 6 weeks (30 sessions) and is intended to stimulate the targeted vlPFC-amygdala circuit.
  • Placebo Comparator: Sham iTBS
    Participants will receive sham iTBS at the same individualized amygdala-connected vlPFC target every weekday for 6 weeks (30 sessions).

Primary Outcome Measure

Average amygdala blood-oxygen-level-dependent (BOLD) signal change following single-pulse fMRI-guided TMS (TMS On vs. TMS Off) to the individualized amygdala-connected target. [ Time Frame: Single visit (~2 hours) ]

Central Contacts

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