- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07336251
Transcranial Magnetic Stimulation in Veterans With PTSD
January 20, 2026 updated by: Bradley Watts, White River Junction Veterans Affairs Medical Center
Transcranial Magnetic Stimulation in Veterans With PTSD: A Pilot Study to Examine Mechanism of Effect
With this research investigators hope to begin to understand how rTMS can improve posttraumatic stress disorder (PTSD) symptoms.
TMS improves PTSD through two interrelated mechanisms: change in brain limbic system function and change in systemic inflammatory activation.
Participants who decide to join this study, will receive ten rTMS treatments.
All participants will undergo a 40-minute rTMS procedure with a member of the study team 10 times over 2-4 weeks.
Participants will undergo fMRI scans of the head in order to help researchers better understand potential effects of rTMS on brain activity.
In addition, participants will be asked to give two breath and blood samples to look for signs of general inflammation.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
20
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 Contact
- Name: Bradley V Watts, MD, MPH
- Phone Number: 5235 802-295-9363
- Email: bradley.watts@va.gov
Study Contact Backup
- Name: Julian Sewall
- Phone Number: 603-266-7140
- Email: julian.sewall@va.gov
Study Locations
-
-
Vermont
-
White River Junction, Vermont, United States, 05001
- Recruiting
- White River Junction VA Hospital
-
Contact:
- Bradley Watts, MD, MPH
- Phone Number: 5235 802-295-9363
- Email: bradley.watts@va.gov
-
Principal Investigator:
- Bradley Watts,MD, MPH
-
Sub-Investigator:
- Brian Shiner MD, MPH
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 19 and 70
- Eligible for VA healthcare
- Moderate to severe PTSD as determined by a total score of at least 25 on the CAPS within 7 days of randomization.
- Agree to have CAPS audio recorded.
- Ability to obtain a Motor Threshold using the TMS device during screening.
- If female with childbearing potential, use of acceptable method of birth control (i.e., use of contraceptives, abstinence).
- Able to read, understand, and sign the informed consent document.
Exclusion Criteria:
- Pregnant or lactating woman.
- MRI is contraindicated
- Current use of clozapine (any dose) or bupropion (more than 300mg per day).
- Cardiac pacemaker or implantable defibrillator.
- Presence of any metal object in the head, including cochlear implants, but excluding dental work in the mouth.
- Significant central nervous system disorder (stroke, brain mass, epilepsy).
- Seizure in past one year.
- Current psychosis or mania.
- Significant suicidal ideation.
- Unstable medical conditions.
- Current alcohol or substance use disorder (except nicotine) that interferes with the patient's ability to participate.
- CPT or PE for PTSD in the past 2 months.
- Changes in Fluoxetine, Paroxetine, Sertraline, or Venlafaxine in the past 2 months.
- Color blind
- Currently participating in other research studies.
- Aneurysm Clip
- Ocular foreign body (e.g., metal shavings)
- Any implanted device (pumps, infusion devices, etc.)
- Shrapnel injuries or metal fragments
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants receiving open label trial of TMS
|
10 sessions of low frequency rTMS (1Hz) applied to the right dorsolateral prefrontal cortex.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Frequency and intensity of PTSD symptoms as assessed by the CAPS-5
Time Frame: From enrollment to the end of treatment at 3 months
|
The CAPS is a clinician-administered scale of PTSD symptoms, which queries the frequency and intensity of symptoms of PTSD
|
From enrollment to the end of treatment at 3 months
|
|
20 item self-report of PTSD symptoms assessed by PCL-5
Time Frame: From enrollment to the end of treatment at 3 months
|
It asks participants to rate the severity of each of the 20 symptoms of PTSD in DSM-5
|
From enrollment to the end of treatment at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
A quick self-reported and self administered inventory of depressive symptoms (QIDS-16-SR)
Time Frame: From the baseline to the end of the study at 3 months
|
This is a self-reported, self- administered scale of depressive symptoms.
|
From the baseline to the end of the study at 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bradley Watts, US Department of Veterans Affairs
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 (Estimated)
January 15, 2026
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Study Registration Dates
First Submitted
January 9, 2026
First Submitted That Met QC Criteria
January 9, 2026
First Posted (Actual)
January 13, 2026
Study Record Updates
Last Update Posted (Actual)
January 21, 2026
Last Update Submitted That Met QC Criteria
January 20, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1869595
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.
Yes
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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