Effect of TMS on PTSD Biomarkers

NCT04563078 | Completed Results DMC FDA Device

• 2 other identifiers: STUDY00000338K01MH121653
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Keywords

Transcranial Magnetic Stimulation; PTSD; Biomarkers; Neuroimaging; Psychophysiology

Outcome Measures

Primary Outcomes (2)

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

  Amygdala reactivity during fear processing were assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli, while amygdala reactivity was measured. The amygdala was separated in the right and left hemispheres. fMRI measures the blood oxygen level-dependent response, a measure of how much more oxygenated blood there is in a certain brain region, which reflects activation of the brain region. A regression model was used to determine the beta value as a measure of brain activity. Across voxels in each region (right amygdala, left amygdala), the beta value for response in the amygdala to Fearful faces and Neutral faces was extracted.

  Baseline, day 10

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

  Change in skin conductance response to trauma cues pre- to post-treatment was assessed. The mobile skin conductance response was measured in microsiemens when participants described their worst trauma, followed by assessment of their symptoms. A numeric value estimating the skin conductance response was calculated by subtracting the baseline skin conductance reactivity from the reactivity during the trauma description.

  Baseline, day 10

Secondary Outcomes (7)

• 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 Hippocampus Pre- to Post-treatment

  Baseline, day 10

• Change in Ventromedial Prefrontal Cortex (vmPFC)-Amygdala Functional Connectivity Pre- to Post-treatment

  Baseline, day 10

• Change in Dorsolateral Prefrontal Cortex (DLPFC)-Amygdala Functional Connectivity Pre- to Post-treatment

  Baseline, day 10

• Change in Fear-Potentiated Startle Responses to Danger and Safety Cues Pre- to Post-treatment.

  Baseline, day 10 (Post TMS)

Study Arms (2)

Transcranial Magnetic Stimulation (TMS)

EXPERIMENTAL

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

Device: Transcranial Magnetic Stimulation (TMS)

Sham Transcranial Magnetic Stimulation (TMS)

SHAM COMPARATOR

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

Procedure: Sham Transcranial Magnetic Stimulation (TMS)

Interventions

Transcranial Magnetic Stimulation (TMS) DEVICE

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.

Transcranial Magnetic Stimulation (TMS)

Sham Transcranial Magnetic Stimulation (TMS) PROCEDURE

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

Sham Transcranial Magnetic Stimulation (TMS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Grady Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Dr. Sanne van Rooij
• Organization: Emory University

sanne.van.rooij@emory.edu

404-251-8926

Study Officials

• Sanne van Rooij, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: February 15, 2021
• Primary Completion: March 28, 2025
• Study Completion: September 28, 2025
• Last Updated: June 1, 2026
• Results First Posted: June 1, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)