Effect of TMS on PTSD Biomarkers

May 4, 2023 updated by: Sanne van Rooij, Emory University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Grady Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Amygdala Reactivity during fear processing pre- to post-treatment
Time Frame: Baseline, day 10
Change in Amygdala Reactivity during fear processing pre- to post-treatment will be assessed
Baseline, day 10
Change in skin conductance response to trauma cues pre- to post-treatment
Time Frame: Baseline, day 10
Change in skin conductance response to trauma cues pre- to post-treatment will be assessed
Baseline, day 10

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Institute of Mental Health (NIMH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2021

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (Actual)

September 24, 2020

Study Record Updates

Last Update Posted (Estimate)

May 5, 2023

Last Update Submitted That Met QC Criteria

May 4, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000338
  • K01MH121653 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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