CompletedNot Applicable

Effect of TMS on PTSD Biomarkers

United States50 participantsStarted 2021-02-15

Plain-language summary

The study will (1) assess feasibility of a TMS treatment in an underserved population; (2) determine if this TMS treatment protocol improves PTSD symptoms and biological markers of PTSD such as brain functioning and startle responses; (3) define new brain targets for future TMS studies; (4) provide the first data for individual differences, which will help personalize treatment for PTSD patients; (5) improve knowledge of the neurobiology of PTSD and treatment response.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men and women 18-65 years of age. * Meet for partial PTSD, defined as 3 out of 4 symptom clusters always including cluster E (alterations in arousal and reactivity) according to the DSM-5 criteria using the Clinician-Administered PTSD Scale (CAPS-5). * Capable and willing to provide informed consent. * Able to adhere to the treatment schedule. Exclusion Criteria: * Having active suicidal intent or plan as defined by a positive answer to questions 4 and/or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS): Screening version; or in the clinician's opinion, is likely to attempt suicide within the next six months. * Unstable psychotropic medication status. Participants taking psychotropic medications (i.e.,antidepressants, antipsychotics, benzodiazepines and anticonvulsants, etc.) can be enrolled in the study as long as medication type and dose has been stable for at least 6 weeks, and additionally, medication type or dose does not change during the course of the study. * Lifetime diagnosis of psychotic disorder or bipolar I disorder per diagnostic interview. * Diagnosed with the following conditions: a neurological disorder, including a history of seizures, cerebrovascular disease, primary or secondary tumors in CNS, stroke, cerebral aneurysm or movement disorder or any lifetime history of loss of consciousness for more than 5 minutes due to head injury. * History of cranial surgery, metallic particles in the eye or head (exclusive of mouth), impl…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Amygdala Reactivity During Fear Processing Pre- to Post-treatment

Timeframe: Baseline, day 10

Change in Skin Conductance Response to Trauma Cues Pre- to Post-treatment

Timeframe: Baseline, day 10

Trial details

NCT IDNCT04563078

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-28

Results submitted2026-03-18

View on ClinicalTrials.gov More Post Traumatic Stress Disorder trials