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Feasibility and Preliminary Efficacy of Functional MRI-Guided Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder: A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study tests a new brain stimulation treatment for post-traumatic stress disorder (PTSD), a condition that affects millions after trauma, causing symptoms like flashbacks, avoidance, mood changes, and heightened alertness. The investigators will enroll 15 adults (ages 18-65) with PTSD. First, participants get a brain scan (fMRI) to map their unique brain connections between areas involved in fear and control-the right amygdala (fear center) and right dorsolateral prefrontal cortex (control area). Using this personalized map, the investigators will apply accelerated transcranial magnetic stimulation (TMS), a safe, non-invasive method using magnetic pulses to adjust brain activity. Treatment lasts 5 days (10 short sessions daily, totaling 90,000 pulses) targeting the identified spot to strengthen control over fear responses. The study checks if this approach is practical, safe (tracking side effects like headaches), and shows early signs of reducing PTSD symptoms (measured by questionnaires and interviews). Follow-up lasts 3 months, with repeat scans to see brain changes. This study will see if personalized, fast-paced TMS targeting the disrupted fear-control brain circuit in PTSD can be feasible and safe, and preliminarily reduce symptoms by improving brain connectivity, potentially offering a quicker alternative to standard treatments.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
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⁃ Participants must meet ALL of the following criteria:

• Age 18-65 years (inclusive)

• DSM-5 diagnosis of PTSD confirmed by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

• PCL-5 total score ≥33 (indicating at least moderate symptom severity)

• PTSD symptom duration ≥3 months

• If taking psychotropic medications, stable dose for ≥6 weeks prior to enrollment with no planned changes during study participation

• Able to provide written informed consent

• English-speaking (required for validated assessment measures)

• Able to attend daily treatment sessions for 5 consecutive weekdays

• Eligible for 1.5T MRI scanning (no contraindications)

Locations
United States
Utah
Cognitive FX TMS Clinic
RECRUITING
Provo
Contact Information
Primary
Lynn Gaufin, MD
tms.info@cognitivefxusa.com
385-446-4158
Backup
Mark Allen, PhD
mark@cognitivefxusa.com
Time Frame
Start Date: 2026-08-14
Estimated Completion Date: 2027-01
Participants
Target number of participants: 15
Treatments
Experimental: Active accelerated TMS stimulation
This is a single-arm, open-label pilot study. All enrolled participants will receive active fMRI-guided accelerated cTBS treatment to the right dorsolateral prefrontal cortex (rDLPFC). The study includes a screening/baseline phase, a 5-day treatment phase, and a 3-month follow-up phase.
Sponsors
Leads: Cognitive FX

This content was sourced from clinicaltrials.gov