NCT07336251

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress32%
Jan 2026Jan 2027

First Submitted

Initial submission to the registry

January 9, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

January 15, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 9, 2026

Last Update Submit

January 20, 2026

Conditions

PTSD - Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

  • Frequency and intensity of PTSD symptoms as assessed by the CAPS-5

    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

    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 Outcomes (1)

  • A quick self-reported and self administered inventory of depressive symptoms (QIDS-16-SR)

    From the baseline to the end of the study at 3 months

Study Arms (1)

Participants receiving open label trial of TMS

EXPERIMENTAL
Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic StimulationDEVICE

10 sessions of low frequency rTMS (1Hz) applied to the right dorsolateral prefrontal cortex.

Participants receiving open label trial of TMS

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

White River Junction VA Hospital

White River Junction, Vermont, 05001, United States

RECRUITING

MeSH Terms

Conditions

Combat Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Bradley Watts

    US Department of Veterans Affairs

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bradley V Watts, MD, MPH

CONTACT

802-295-9363bradley.watts@va.gov

Julian Sewall

CONTACT

603-266-7140julian.sewall@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Psychiatrist

Study Record Dates

First Submitted

January 9, 2026

First Posted

January 13, 2026

Study Start

January 15, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

US(1)