Using magnetic stimulation to help veterans with PTSD
Transcranial Magnetic Stimulation to Improve Functioning in Veterans With PTSD
This study is testing if a special type of magnetic treatment can help veterans with PTSD feel better and improve their daily lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 91 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (White River Junction, Vermont) |
| Trial ID | NCT04207346 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of transcranial magnetic stimulation (TMS) in improving functioning and reducing symptoms in veterans diagnosed with PTSD. A total of 91 veterans will be randomly assigned to receive either active TMS or a sham treatment, with the TMS targeting the right dorsolateral prefrontal cortex. The study aims to assess changes in PTSD symptoms, functional outcomes, and depressive symptoms at treatment completion, as well as at 3 and 6 months post-treatment. The goal is to determine if TMS can provide a beneficial alternative for veterans who have not responded to traditional therapies.
Who should consider this trial
Good fit: Ideal candidates are veterans with moderate to severe PTSD who are eligible for VA healthcare.
Not a fit: Patients who are pregnant, have certain medical implants, or have a history of significant psychiatric disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for veterans suffering from PTSD, potentially improving their quality of life.
How similar studies have performed: While TMS has shown effectiveness in treating depression, its application for PTSD is still being explored, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
White River Junction, Vermont
- White River Junction VA Medical Center, White River Junction, VT — White River Junction, Vermont, United States (Recruiting)
Study contacts
- Principal investigator: Bradley V Watts, MD MPH — White River Junction VA Medical Center, White River Junction, VT
- Study coordinator: Bradley V Watts, MD MPH
- Email: Bradley.Watts@va.gov
- Phone: (802) 295-9363
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.