Post Traumatic Stress DisorderNCT04563078
Effect of TMS on PTSD Biomarkers
A study testing Transcranial Magnetic Stimulation (TMS) in people with Post Traumatic Stress Disorder, run by Emory University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Transcranial Magnetic Stimulation (TMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2021to 28 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Transcranial Magnetic Stimulation (TMS), Sham Transcranial Magnetic Stimulation (TMS)
- Keywords
- Transcranial Magnetic Stimulation, PTSD, Biomarkers, Neuroimaging, Psychophysiology
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sham Transcranial Magnetic Stimulation (TMS)Procedure or surgery
10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Experimental | TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions. Receives: Device: Transcranial Magnetic Stimulation (TMS) |
| Sham Transcranial Magnetic Stimulation (TMS) | Sham comparator | Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted. Receives: Procedure: Sham Transcranial Magnetic Stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, day 10
Secondary outcomes (7)
Change in Inhibition-related Activation in the Ventromedial Prefrontal Cortex (vmPFC) Pre- to Post-treatment
Change in inhibition-related activation in the vmPFC was assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli. At the same time, reactivity in the ventromedial prefrontal cortex was measured. Across voxels in the ventromedial prefrontal cortex, a contrast estimate of responses to Fearful > Neutral faces was extracted.
This is being reported as a numeric value estimating inhibition-related brain activation (contrast estimate fear versus neutral)
Measured: Baseline, day 10
Change in Inhibition-related Activation in the Hippocampus Pre- to Post-treatment
Change in inhibition-related activation in the hippocampus was assessed by fMRI responses as participants viewed 15 blocks each of fearful face and neutral face stimuli, while hippocampal reactivity was measured.
The hippocampus was separated into the right and left hemispheres. Across voxels in each region (right hippocampus, left hippocampus), a contrast estimate of Fearful > Neutral faces was extracted.
Measured: Baseline, day 10
Change in Ventromedial Prefrontal Cortex (vmPFC)-Amygdala Functional Connectivity Pre- to Post-treatment
Change in vmPFC-amygdala functional connectivity pre- to post-treatment was assessed. A numeric value estimating the correlation between the vmPFC and amygdala was measured.
Measured: Baseline, day 10
Change in Dorsolateral Prefrontal Cortex (DLPFC)-Amygdala Functional Connectivity Pre- to Post-treatment
Change in DLPFC-amygdala functional connectivity pre- to post-treatment was assessed. A numeric value estimating the correlation between the DLPFC and amygdala was measured.
Measured: Baseline, day 10
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 was assessed. An eye blink response was measured using electromyography with sensors placed near the eyes. Symbols were presented on a screen, one symbol followed by an airblast to the throat was the danger cue and a different symbol not followed by the airblast was the safety cue. The eye blink response in response to danger and safety cues was measured.
Measured: Baseline, day 10 (Post TMS)
Change in Discrimination Between Danger and Safety Cues Pre- to Post-treatment
Change in discrimination between danger and safety cues pre- to post-treatment was assessed. An eye blink response was measured using electromyography with sensors placed near the eyes. Symbols were presented on a screen, with one symbol followed by an airblast to the throat serving as the danger cue, and a different symbol, not followed by the airblast, serving as the safety cue. The eye blink response in response to danger and safety cues was measured. The difference score for the eye blink response to danger and safety was calculated.
Measured: Baseline, day 10
Change in Post-traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Pre- to Post-treatment
The severity of self-reported PTSD hyperarousal symptoms was assessed with the PCL-5, sub-cluster E. The PCL-5 asks participants to recall the worst stressful event that is currently bothering them the most. Keeping this event in mind, participants respond to 20 questions indicating how bothered they have been by PTSD symptoms. Responses are on a 5-point scale, where 0 = not bothered at all and 4 = extremely bothered. The 6 questions related to hyperarousal were used. Total raw scores range from 0 to 24, where higher scores indicate greater distress from PTSD hyperarousal symptoms.
Measured: Baseline, day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start15 Feb 2021
- Primary completion28 Mar 2025
- Study completion28 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sanne van Rooij, Emory University
- Investigators
- Sanne van Rooij, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04563078
- Sponsor's protocol ID
- STUDY00000338
- Other IDs
- K01MH121653
- Status last verified
- May 2026
- First submitted
- 18 Sep 2020
- Last updated
- 1 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transcranial Magnetic Stimulation (TMS) on PTSD Neuroimaging and Psychophysiological Biomarkers
- ClinicalTrials.gov ID
- NCT04563078
- Acronym / sponsor ID
- STUDY00000338
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- Transcranial Magnetic Stimulation, PTSD, Biomarkers, Neuroimaging, Psychophysiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Feb 2021 (actual)
- Primary completion
- 28 Mar 2025 (actual)
- Study completion
- 28 Sep 2025 (actual)
- First posted
- 24 Sep 2020 (actual)
- Results
- Posted 1 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial Magnetic Stimulation (TMS) | Experimental | Device: Transcranial Magnetic Stimulation (TMS)TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions. |
| Sham Transcranial Magnetic Stimulation (TMS) | Sham comparator | Procedure: Sham Transcranial Magnetic Stimulation (TMS)Sessions of Sham Transcranial Magnetic Stimulation (TMS) will be conducted. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Transcranial Magnetic Stimulation (TMS) |
| Sham Transcranial Magnetic Stimulation (TMS)10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control. | Procedure or surgery | Sham Transcranial Magnetic Stimulation (TMS) |
Primary outcome
Change in Amygdala Reactivity During Fear Processing Pre- to Post-treatment
Time frame: Baseline, day 10
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.
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 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.
7 secondary outcomes
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 Hippocampus Pre- to Post-treatment
Time frame: Baseline, day 10
Change in Ventromedial Prefrontal Cortex (vmPFC)-Amygdala Functional Connectivity Pre- to Post-treatment
Time frame: Baseline, day 10
Change in Dorsolateral Prefrontal Cortex (DLPFC)-Amygdala Functional Connectivity Pre- to Post-treatment
Time frame: Baseline, day 10
Change in Fear-Potentiated Startle Responses to Danger and Safety Cues Pre- to Post-treatment.
Time frame: Baseline, day 10 (Post TMS)
Change in Discrimination Between Danger and Safety Cues Pre- to Post-treatment
Time frame: Baseline, day 10
Change in Post-traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Pre- to Post-treatment
Time frame: Baseline, day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanne van Rooij, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation (TMS) in people with Post Traumatic Stress Disorder, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Amygdala Reactivity During Fear Processing Pre- to Post-treatment (time frame: Baseline, day 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.