Transcranial Magnetic Stimulation to Improve Functioning in Veterans With PTSD

NCT04207346 | Completed DMC FDA Device

• 1 other identifier: D2905-R
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTSD

Keywords

Transcranial Magnetic Stimulation; Stress Disorders, Post-Traumatic

Outcome Measures

Primary Outcomes (12)

• 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.

  Baseline

• 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.

  Baseline

• 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.

  Baseline

• 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.

  2 weeks

• 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.

  3 months

• 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.

  6 months

• 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.

  2 weeks

• 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.

  3 months

• 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.

  6 months

• 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.

  2 weeks

• 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.

  3 months

• 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.

  6 months

Study Arms (2)

TMS

EXPERIMENTAL

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

Device: TMS 1 hz

Sham

SHAM COMPARATOR

sham transcranial magnetic stimulation delivered to the right dorsolateral prefrontal cortex

Device: Sham TMS

Interventions

TMS 1 hz DEVICE

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

TMS

Sham TMS DEVICE

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

Sham

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 19 and 70
• Moderate to severe PTSD as determined by 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.
• Patient eligible for VA healthcare.
• 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.
• 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.
• Prior use of TMS.
• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

White River Junction VA Medical Center, White River Junction, VT

White River Junction, Vermont, 05001-3833, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Bradley V Watts, MD MPH

  White River Junction VA Medical Center, White River Junction, VT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two or more groups in parallel for the duration of the study: procedure vs. sham procedure

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 20, 2019
• Study Start: December 1, 2020
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)