Clinical trial NCT04563078: Effect of TMS on PTSD Biomarkers
Official title: Effect of Transcranial Magnetic Stimulation (TMS) on PTSD Neuroimaging and Psychophysiological Biomarkers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Keywords: Transcranial Magnetic Stimulation
PTSD
Biomarkers
Neuroimaging
Psychophysiology
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-09-24
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Posttraumatic stress disorder is a psychiatric disorder that can develop in response to a traumatic event, and half of civilians living in inner-city areas with high levels of violence suffer from PTSD. The currently recommended treatment for PTSD is focused on discussing the trauma, but a third to half of patients cannot participate or do not benefit from this treatment, especially individuals with low levels of education or literacy. Therefore, new treatments for PTSD are needed.

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.

Eligibility criteria: 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), implanted cardiac pacemaker or any intra-cardiac lines, implanted neurostimulators, intra-cranial implants (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or implanted medical pumps.
* Current substance abuse or dependence as indicated by a score of 6 or higher on the Drug Abuse Screening Test (DAST).
* Current alcohol abuse or dependence as indicated by a score of 8 or higher on the Alcohol Use Disorder Identification Test (AUDIT).
* Being pregnant or a positive pregnancy test at the beginning of each TMS treatment week for sexually active women of childbearing age who are on reliable birth control.
* Currently participating in another clinical study or enrolled in another clinical study within 30 days prior to this study or started (new) treatment for PTSD within 3 months prior to this study.
* Previously treated with TMS.

Primary outcomes:
measure: Change in Amygdala Reactivity during fear processing pre- to post-treatment
timeFrame: Baseline, day 10
measure: Change in skin conductance response to trauma cues pre- to post-treatment
timeFrame: Baseline, day 10
Secondary outcomes:
measure: Change in inhibition-related activation in the ventromedial prefrontal cortex (vmPFC) pre- to post-treatment
timeFrame: Baseline, day 10
measure: Change in inhibition-related activation in the hippocampus pre- to post-treatment
timeFrame: Baseline, day 10
measure: Change in ventromedial prefrontal cortex (vmPFC)-amygdala functional connectivity pre- to post-treatment
timeFrame: Baseline, day 10
measure: Change in dorsolateral prefrontal cortex (DLPFC)-amygdala functional connectivity pre- to post-treatment
timeFrame: Baseline, day 10
measure: Change in Fear-Potentiated Startle Responses to danger and safety cues pre- to post-treatment.
timeFrame: Baseline, day 10
measure: Change in discrimination between danger and safety cues pre- to post-treatment
timeFrame: Baseline, day 10
measure: Change in Post-traumatic stress disorder (PTSD) hyperarousal symptoms pre- to post-treatment
timeFrame: Baseline, day 10
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Sanne van Rooij, PhD
role: PRINCIPAL_INVESTIGATOR
References: