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Effect of TMS on PTSD Biomarkers

Primary Purpose

Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
Sham Transcranial Magnetic Stimulation (TMS)
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Traumatic Stress Disorder focused on measuring Transcranial Magnetic Stimulation, PTSD, Biomarkers, Neuroimaging, Psychophysiology

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Grady HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Transcranial Magnetic Stimulation (TMS)

Sham Transcranial Magnetic Stimulation (TMS)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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
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
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
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
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
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

Full Information

First Posted
September 18, 2020
Last Updated
May 4, 2023
Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04563078
Brief Title
Effect of TMS on PTSD Biomarkers
Official Title
Effect of Transcranial Magnetic Stimulation (TMS) on PTSD Neuroimaging and Psychophysiological Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2021 (Actual)
Primary Completion Date
April 1, 2025 (Anticipated)
Study Completion Date
July 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Traumatic Stress Disorder
Keywords
Transcranial Magnetic Stimulation, PTSD, Biomarkers, Neuroimaging, Psychophysiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial Magnetic Stimulation (TMS)
Arm Type
Experimental
Arm Description
TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
Arm Title
Sham Transcranial Magnetic Stimulation (TMS)
Arm Type
Sham Comparator
Arm Description
Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted.
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Sham Transcranial Magnetic Stimulation (TMS)
Intervention Description
10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
Primary Outcome Measure Information:
Title
Change in Amygdala Reactivity during fear processing pre- to post-treatment
Description
Change in Amygdala Reactivity during fear processing pre- to post-treatment will be assessed
Time Frame
Baseline, day 10
Title
Change in skin conductance response to trauma cues pre- to post-treatment
Description
Change in skin conductance response to trauma cues pre- to post-treatment will be assessed
Time Frame
Baseline, day 10
Secondary Outcome Measure Information:
Title
Change in inhibition-related activation in the ventromedial prefrontal cortex (vmPFC) pre- to post-treatment
Description
Change in inhibition-related activation in the ventromedial prefrontal cortex (vmPFC) pre- to post-treatment will be assessed
Time Frame
Baseline, day 10
Title
Change in inhibition-related activation in the hippocampus pre- to post-treatment
Description
Change in inhibition-related activation in the hippocampus pre- to post-treatment will be assessed
Time Frame
Baseline, day 10
Title
Change in ventromedial prefrontal cortex (vmPFC)-amygdala functional connectivity pre- to post-treatment
Description
Change in vmPFC-amygdala functional connectivity pre- to post-treatment will be assessed
Time Frame
Baseline, day 10
Title
Change in dorsolateral prefrontal cortex (DLPFC)-amygdala functional connectivity pre- to post-treatment
Description
Change in DLPFC-amygdala functional connectivity pre- to post-treatment will be assessed
Time Frame
Baseline, day 10
Title
Change in Fear-Potentiated Startle Responses to danger and safety cues pre- to post-treatment.
Description
Change in Fear-Potentiated Startle Responses to danger and safety cues pre- to post-treatment will be assessed
Time Frame
Baseline, day 10
Title
Change in discrimination between danger and safety cues pre- to post-treatment
Description
Change in discrimination between danger and safety cues pre- to post-treatment will be assessed
Time Frame
Baseline, day 10
Title
Change in Post-traumatic stress disorder (PTSD) hyperarousal symptoms pre- to post-treatment
Description
Change in PTSD hyperarousal symptoms pre- to post-treatment will be assessed
Time Frame
Baseline, day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sanne van Rooij, PhD
Phone
404-251-8926
Email
sanne.van.rooij@emory.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanne van Rooij, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanne van Rooij, PhD
Phone
404-251-8926
Email
sanne.van.rooij@emory.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of TMS on PTSD Biomarkers

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