Effect of TMS on PTSD Biomarkers (NCT04563078) | Clinical Trial Compass
CompletedNot Applicable
Effect of TMS on PTSD Biomarkers
United States63 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 range18 Years – 65 Years
SexALL
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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…
What they're measuring
1
Change in Amygdala Reactivity during fear processing pre- to post-treatment
Timeframe: Baseline, day 10
2
Change in skin conductance response to trauma cues pre- to post-treatment