Effect of TMS on PTSD Biomarkers

Sponsor

Emory University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04563078

Collaborator

National Institute of Mental Health (NIMH) (NIH)

Enrollment

Location

Arms

52.5

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder	Device: Transcranial Magnetic Stimulation (TMS) Procedure: Sham Transcranial Magnetic Stimulation (TMS)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Transcranial Magnetic Stimulation (TMS) on PTSD Neuroimaging and Psychophysiological Biomarkers

Actual Study Start Date :

Feb 15, 2021

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Transcranial Magnetic Stimulation (TMS) TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.	Device: Transcranial Magnetic Stimulation (TMS) 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Sham Comparator: Sham Transcranial Magnetic Stimulation (TMS) Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.	Procedure: Sham Transcranial Magnetic Stimulation (TMS) 10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.

Arm

Intervention/Treatment

Experimental: Transcranial Magnetic Stimulation (TMS)

TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.

Device: Transcranial Magnetic Stimulation (TMS)

10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.

Sham Comparator: Sham Transcranial Magnetic Stimulation (TMS)

Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.

Procedure: Sham Transcranial Magnetic Stimulation (TMS)

10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.

Outcome Measures

Primary Outcome Measures

Change in Amygdala Reactivity during fear processing pre- to post-treatment [Baseline, day 10]
Change in Amygdala Reactivity during fear processing pre- to post-treatment will be assessed
Change in skin conductance response to trauma cues pre- to post-treatment [Baseline, day 10]
Change in skin conductance response to trauma cues pre- to post-treatment will be assessed

Secondary Outcome Measures

Change in inhibition-related activation in the ventromedial prefrontal cortex (vmPFC) pre- to post-treatment [Baseline, day 10]
Change in inhibition-related activation in the ventromedial prefrontal cortex (vmPFC) pre- to post-treatment will be assessed
Change in inhibition-related activation in the hippocampus pre- to post-treatment [Baseline, day 10]
Change in inhibition-related activation in the hippocampus pre- to post-treatment will be assessed
Change in ventromedial prefrontal cortex (vmPFC)-amygdala functional connectivity pre- to post-treatment [Baseline, day 10]
Change in vmPFC-amygdala functional connectivity pre- to post-treatment will be assessed
Change in dorsolateral prefrontal cortex (DLPFC)-amygdala functional connectivity pre- to post-treatment [Baseline, day 10]
Change in DLPFC-amygdala functional connectivity pre- to post-treatment will be assessed
Change in Fear-Potentiated Startle Responses to danger and safety cues pre- to post-treatment. [Baseline, day 10]
Change in Fear-Potentiated Startle Responses to danger and safety cues pre- to post-treatment will be assessed
Change in discrimination between danger and safety cues pre- to post-treatment [Baseline, day 10]
Change in discrimination between danger and safety cues pre- to post-treatment will be assessed
Change in Post-traumatic stress disorder (PTSD) hyperarousal symptoms pre- to post-treatment [Baseline, day 10]
Change in PTSD hyperarousal symptoms pre- to post-treatment will be assessed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.