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Effect of TMS on PTSD Biomarkers

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ClinicalTrials.gov Identifier: NCT04563078
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : February 1, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sanne van Rooij, Emory University

Study Description
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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) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 15, 2021
Estimated Primary Completion Date : July 1, 2024
Estimated Study Completion Date : July 1, 2025
Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563078


Contacts
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Contact: Sanne van Rooij, PhD 404-251-8926 sanne.van.rooij@emory.edu

Locations
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United States, Georgia
Grady Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sanne van Rooij, PhD    404-251-8926    sanne.van.rooij@emory.edu   
Sponsors and Collaborators
Emory University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Sanne van Rooij, PhD Emory University
More Information
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Responsible Party: Sanne van Rooij, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT04563078    
Other Study ID Numbers: STUDY00000338
K01MH121653 ( U.S. NIH Grant/Contract )
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: February 1, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Sanne van Rooij, Emory University:
Transcranial Magnetic Stimulation
PTSD
Biomarkers
Neuroimaging
Psychophysiology
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders