Effect of TMS on PTSD Biomarkers

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04563078
• Other study ID #: STUDY00000338
• Secondary ID: K01MH121653
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2021
• Est. completion date: July 1, 2026

Study information

• Verified date: May 2024
• Source: Emory University
• Contact: Sanne van Rooij, PhD
• Phone: 404-251-8926
• Email: sanne.van.rooij[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.

Procedure:
• Sham Transcranial Magnetic Stimulation (TMS)
10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.

Locations

Country	Name	City	State
United States	Grady Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Amygdala Reactivity during fear processing pre- to post-treatment	Change in Amygdala Reactivity during fear processing pre- to post-treatment will be assessed	Baseline, day 10
Primary	Change in skin conductance response to trauma cues pre- to post-treatment	Change in skin conductance response to trauma cues pre- to post-treatment will be assessed	Baseline, day 10
Secondary	Change in inhibition-related activation in the ventromedial prefrontal cortex (vmPFC) pre- to post-treatment	Change in inhibition-related activation in the ventromedial prefrontal cortex (vmPFC) pre- to post-treatment will be assessed	Baseline, day 10
Secondary	Change in inhibition-related activation in the hippocampus pre- to post-treatment	Change in inhibition-related activation in the hippocampus pre- to post-treatment will be assessed	Baseline, day 10
Secondary	Change in ventromedial prefrontal cortex (vmPFC)-amygdala functional connectivity pre- to post-treatment	Change in vmPFC-amygdala functional connectivity pre- to post-treatment will be assessed	Baseline, day 10
Secondary	Change in dorsolateral prefrontal cortex (DLPFC)-amygdala functional connectivity pre- to post-treatment	Change in DLPFC-amygdala functional connectivity pre- to post-treatment will be assessed	Baseline, day 10
Secondary	Change in Fear-Potentiated Startle Responses to danger and safety cues pre- to post-treatment.	Change in Fear-Potentiated Startle Responses to danger and safety cues pre- to post-treatment will be assessed	Baseline, day 10
Secondary	Change in discrimination between danger and safety cues pre- to post-treatment	Change in discrimination between danger and safety cues pre- to post-treatment will be assessed	Baseline, day 10
Secondary	Change in Post-traumatic stress disorder (PTSD) hyperarousal symptoms pre- to post-treatment	Change in PTSD hyperarousal symptoms pre- to post-treatment will be assessed	Baseline, day 10