Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder

NCT07463703 | Not Yet Recruiting FDA Device

• 1 other identifier: COMPASS-PTSD-1.0.0
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD - Post Traumatic Stress Disorder

Keywords

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• PTSD Checklist for DSM-5 (PCL-5)

  A change in PTSD severity will be measured via administration of the PDSD Checklist for DSM-5 (PCL-5). This is a 20-question Likert scale, with scores ranging from 0 to 80. Higher scores indicate stronger PTSD symptoms.

  Baseline, post-treatment 5 days, 1 month, 3 months

Secondary Outcomes (4)

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

  Baseline, post-treatment 5 days, 3 months

• Beck Depression Inventory-II (BDI-II)

  Baseline, post-treatment 5 days, 1 month, 3 months

• Patient Global Impression of Change (PGI-C)

  Post-treatment 5 days, 3 months

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Baseline, treatment days 1, 2, 3, 4, and 5, post-treatment 5 days, 1 month, 3 months

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Treatment initiation through 3 months post-treatment (approx. 95 days total)

Study Arms (1)

Active accelerated TMS stimulation

EXPERIMENTAL

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.

Device: Accelerated functional-connectivity guided transcranial magnetic stimulation

Interventions

Accelerated functional-connectivity guided transcranial magnetic stimulation DEVICE

Resting state functional connectivity scanning will be used to identify the peak positive correlate of the right amygdala in the right dorsolateral prefrontal cortex. This target will be stimulated during 50 sessions over 5 days, 10 sessions per day. Each TMS session will consist of 3 trains of 600-pulse continuous theta burst stimulation (cTBS). Each train consists of 3-pulse 50-Hz bursts at 5-Hz for 40-second trains, with trains every 70 seconds. This stimulation will be applied at 80% of the patient's resting motor threshold. Target site will be identified using ANT Neuro Visor2 neuronavigation system.

Active accelerated TMS stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Participants meeting ANY of the following criteria will be excluded:
• TMS Contraindications:
• Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head or within 30 cm of the TMS coil (excluding the mouth), including:
• Cochlear implants
• Deep brain stimulators
• Vagus nerve stimulators
• Aneurysm clips or coils
• Stents in the neck or brain
• Electrodes
• Any implanted electronic devices
• History of seizure disorder (excluding single childhood febrile seizure)
• First-degree family member with epilepsy
• History of significant head trauma with loss of consciousness \>10 minutes
• History of stroke, brain tumor, or other neurological disorder
• Neurosurgical procedures involving brain tissue

Sponsors & Collaborators

• Cognitive FX: lead

Study Sites (1)

Cognitive FX TMS Clinic

Provo, Utah, 84604, United States

Location

MeSH Terms

Conditions

Combat Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Central Study Contacts

Lynn Gaufin, MD

CONTACT

385-446-4158; tms.info@cognitivefxusa.com

Mark Allen, PhD

CONTACT

mark@cognitivefxusa.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2026
• First Posted: March 11, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 3 months following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal can access the data upon request via email to tms.info@cognitivefxusa.com

Locations

US (1)