CClinicalTrials.gg
CompletedNCT04207346rTMS for PTSDUpdated Jun 18, 2026

Transcranial Magnetic Stimulation to Improve Functioning in Veterans With PTSD

An interventional study of TMS 1 hz and Sham TMS in PTSD, sponsored by VA Office of Research and Development. Completed at 1 site in United States. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-18.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2025, 1 year ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Randomized
Ages
19 Years to 70 Years
Sex
All
01

Study summary

Posttraumatic Stress Disorder (PTSD) is a common and serious condition affecting many Veterans. There are effective treatments for PTSD, but additional treatments are needed in order to better serve Veterans suffering from PTSD. Transcranial magnetic stimulation is one such promising treatment. It involves use of powerful magnet to stimulate the specific brain regions in Veterans with PTSD. Transcranial magnetic stimulation has been shown effective in treating depression, but currently it is unclear if it is an effective treatment for PTSD. This is a randomized clinical trial enrolling 91 Veterans with PTSD comparing the effectiveness of transcranial magnetic stimulation treatment and sham transcranial magnetic stimulation in treating PTSD. The hypothesis is that those who receive transcranial magnetic stimulation will experience improved functioning.

Read the detailed description

Background Posttraumatic Stress Disorder (PTSD) is an often chronic and disabling condition prevalent in the Veteran population. While there is sufficient evidence to demonstrate the effectiveness of medications and psychotherapy for improving PTSD symptoms, there has been limited study of functioning as an outcome, and the role of other treatments such as somatic therapies. One promising but understudied somatic treatment for PTSD is repetitive transcranial magnetic stimulation (TMS). The characteristics of TMS treatment are different than those of existing treatments and may provide alternative treatment to Veterans who do not respond to medications and psychotherapy. Further, it is possible that TMS may have a greater effect on functioning and lead to higher rates of recovery compared with medications or psychotherapy.

Objective To determine whether Veteran participants with PTSD who receive TMS delivered to the right dorsolateral prefrontal cortex at 1 Hz have greater improvements in: PTSD symptoms, functioning, and depressive symptoms than Veterans receiving sham treatments at treatment completion and at 3 and 6 months after treatment completion.

Method 91 Veterans with PTSD will be randomly assigned to receive low frequency TMS or sham TMS. All TMS will be applied to the right dorsolateral prefrontal cortex. PTSD symptoms, functional outcomes, and depressive symptoms will be measured for all participants at treatment completion, 3 months, and 6 months after completion.

Hypothesis Veterans with PTSD receiving TMS will have greater improvements in PTSD symptoms, functioning, and depressive symptoms at treatment completion and at three and six months after treatment completion compared to Veterans receiving sham TMS.

02

Conditions studied

  • PTSD

Keywords

  • Transcranial Magnetic Stimulation
  • Stress Disorders, Post-Traumatic
03

In context

Stress Disorders, Post-Traumatic

2,239 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 554 are open to participants now.

This study's enrollment of 59 is below the median of 70 across 1,858 interventional studies indexed under Stress Disorders, Post-Traumatic.

Browse Stress Disorders, Post-Traumatic studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Age between 19 and 70
  2. Moderate to severe PTSD as determined by the CAPS within 7 days of randomization.
  3. Agree to have CAPS audio-recorded.
  4. Ability to obtain a Motor Threshold using the TMS device during screening.
  5. Patient eligible for VA healthcare.
  6. If female with childbearing potential, use of acceptable method of birth control (i.e., use of contraceptives, abstinence).
  7. Able to read, understand, and sign the informed consent document.

Exclusion criteria

Exclusion Criteria:

  1. Pregnant or lactating woman.
  2. Current use of clozapine (any dose) or bupropion (more than 300mg per day).
  3. Cardiac pacemaker or implantable defibrillator.
  4. Presence of any metal object in the head, including cochlear implants, but excluding dental work in the mouth.
  5. Significant central nervous system disorder (stroke, brain mass, epilepsy).
  6. Seizure in past one year.
  7. Current psychosis or mania.
  8. Prior use of TMS.
  9. Significant suicidal ideation.
  10. Unstable medical conditions.
  11. Current alcohol or substance use disorder (except nicotine) that interferes with the patient's ability to participate.
  12. CPT or PE for PTSD in the past 2 months.
  13. Changes in Fluoxetine, Paroxetine, Sertraline, or Venlafaxine in the past 2 months.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    TMS

    transcranial magnetic stimulation delivered to the right dorsolateral prefrontal cortex at 1 Hz

    Device: TMS 1 hz

  • Sham comparator
    Sham

    sham transcranial magnetic stimulation delivered to the right dorsolateral prefrontal cortex

    Device: Sham TMS

Interventions

  • DeviceTMS 1 hz

    High-performance magnetic stimulator designed for clinical use or use in clinical trials. This specific device has a coil designed with one side that delivers active treatment and the other side that delivers sham (no stimulation) treatment. The sham side is externally identical to the active side, but internally it has a shield that prevents any magnetic energy from interacting with the patient. This arm will use the active side.

    Also known as: MagPro R30 TMS device produced by MagVenture

  • DeviceSham TMS

    High-performance magnetic stimulator designed for clinical use or use in clinical trials. This specific device has a coil designed with one side that delivers active treatment and the other side that delivers sham (no stimulation) treatment. The sham side is externally identical to the active side, but internally it has a shield that prevents any magnetic energy from interacting with the patient. This arm will use the sham side.

    Also known as: MagPro R30 TMS device produced by MagVenture

06

What researchers measure

Primary outcomes

  1. CAPS

    The Clinician-administered scale of PTSD symptoms (CAPS) queries the frequency and intensity of symptoms of PTSD. The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies.

    Time frame: Baseline

  2. WHODAS

    The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) is a 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-100 with a higher score indicating worse functioning.

    Time frame: Baseline

  3. QIDS SR-16

    The Quick Inventory of Depressive Symptomatology (QIDS SR-16) is a 16-item self-report measure of depression. The QIDS SR-16 includes nine domains that relate to the nine primary symptoms of major depressive disorder in the DSM-IV. The score ranges from 0-27 with a higher score indicating worse depression.

    Time frame: Baseline

  4. CAPS

    The Clinician-administered scale of PTSD symptoms (CAPS) queries the frequency and intensity of symptoms of PTSD. The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies.

    Time frame: 2 weeks

  5. CAPS

    The Clinician-administered scale of PTSD symptoms (CAPS) queries the frequency and intensity of symptoms of PTSD. The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies.

    Time frame: 3 months

  6. CAPS

    The Clinician-administered scale of PTSD symptoms (CAPS) queries the frequency and intensity of symptoms of PTSD. The score ranges from 0-80 with a higher score indicating worse symptoms. It is considered the gold standard for diagnosis and symptoms assessment in PTSD clinical studies.

    Time frame: 6 months

  7. WHODAS

    The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) is a 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-100 with a higher score indicating worse functioning.

    Time frame: 2 weeks

  8. WHODAS

    The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) is a 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-100 with a higher score indicating worse functioning.

    Time frame: 3 months

  9. WHODAS

    The World Health Organization Disability Assessment Schedule 2.0 (WHODAS) is a 36 item self-report instrument that assesses disability and function across six domains: communicating, getting around, self-care, getting along with people, life activities, and participation in society. The WHODAS has been used as an outcome of function and disability across many disorders and is commonly used in mental health treatment trials. The total score ranges from 0-100 with a higher score indicating worse functioning.

    Time frame: 6 months

  10. QIDS SR-16

    The Quick Inventory of Depressive Symptomatology (QIDS SR-16) is a 16-item self-report measure of depression. The QIDS SR-16 includes nine domains that relate to the nine primary symptoms of major depressive disorder in the DSM-IV. The score ranges from 0-27 with a higher score indicating worse depression.

    Time frame: 2 weeks

  11. QIDS SR-16

    The Quick Inventory of Depressive Symptomatology (QIDS SR-16) is a 16-item self-report measure of depression. The QIDS SR-16 includes nine domains that relate to the nine primary symptoms of major depressive disorder in the DSM-IV. The score ranges from 0-27 with a higher score indicating worse depression.

    Time frame: 3 months

  12. QIDS SR-16

    The Quick Inventory of Depressive Symptomatology (QIDS SR-16) is a 16-item self-report measure of depression. The QIDS SR-16 includes nine domains that relate to the nine primary symptoms of major depressive disorder in the DSM-IV. The score ranges from 0-27 with a higher score indicating worse depression.

    Time frame: 6 months

07

Study locations

1 site
  • White River Junction VA Medical Center, White River Junction, VT
    White River Junction, Vermont 05001-3833, United States
08

References and documents

Study documents

  • Informed consent form · Jan 12, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04207346
Lead sponsor
VA Office of Research and Development
Responsible party
Sponsor
First posted
Dec 20, 2019
Start date
Dec 1, 2020
Primary completion
Sep 30, 2025
Completion
Sep 30, 2025
Last update
Jun 18, 2026

Study contacts

Bradley V Watts, MD MPH
principal investigator · White River Junction VA Medical Center, White River Junction, VT

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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