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NCT07463703

Accelerated Transcranial Magnetic Stimulation for Post-Traumatic Stress Disorder

Sponsor: Cognitive FX

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04

Completion Date

2027-01

Last Updated

2026-03-11

Healthy Volunteers

Conditions

PTSD - Post Traumatic Stress Disorder

Interventions

DEVICE

Accelerated functional-connectivity guided transcranial magnetic stimulation

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.

Inclusion Criteria Participants must meet ALL of the following criteria: 1. Age 18-65 years (inclusive) 2. DSM-5 diagnosis of PTSD confirmed by Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) 3. PCL-5 total score ≥33 (indicating at least moderate symptom severity) 4. PTSD symptom duration ≥3 months 5. If taking psychotropic medications, stable dose for ≥6 weeks prior to enrollment with no planned changes during study participation 6. Able to provide written informed consent 7. English-speaking (required for validated assessment measures) 8. Able to attend daily treatment sessions for 5 consecutive weekdays 9. Eligible for 1.5T MRI scanning (no contraindications) Exclusion Criteria Participants meeting ANY of the following criteria will be excluded: TMS Contraindications: 1. 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 2. History of seizure disorder (excluding single childhood febrile seizure) 3. First-degree family member with epilepsy 4. History of significant head trauma with loss of consciousness \>10 minutes 5. History of stroke, brain tumor, or other neurological disorder 6. Neurosurgical procedures involving brain tissue MRI Contraindications: 1. Implanted medical devices incompatible with MRI 2. Claustrophobia preventing MRI scan completion 3. Body size preventing MRI scanner entry Psychiatric Exclusions: 1. Lifetime history of psychotic disorder (schizophrenia, schizoaffective disorder, delusional disorder) 2. Lifetime history of bipolar I disorder 3. Current (within past month) moderate or severe substance use disorder per DSM-5 criteria 4. Current active suicidal ideation with intent or plan (Columbia Suicide Severity Rating Scale score ≥4) 5. Psychiatric hospitalization within past 3 months Medical Exclusions: 6. Unstable medical condition that, in the investigator's judgment, would interfere with study participation or pose safety risk 7. Pregnancy or breastfeeding (females of childbearing potential must have negative urine pregnancy test at screening) 8. Prior TMS treatment within past 3 months 9. Current participation in another interventional research study 10. Initiation of psychotherapy specifically for PTSD within past 3 months (stable ongoing therapy is permitted)

Locations (1)

Cognitive FX TMS Clinic

Provo, Utah, United States