Transcranial Magnetic Stimulation to Improve Functioning in Veterans With PTSD (NCT04207346) | Clinical Trial Compass
CompletedNot Applicable
Transcranial Magnetic Stimulation to Improve Functioning in Veterans With PTSD
United States59 participantsStarted 2020-12-01
Plain-language 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.
Who can participate
Age range
19 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used Transcranial Magnetic Stimulation — a non-drug brain stimulation approach — specifically for PTSD in veterans; could you walk me through how TMS works for PTSD and whether my particular symptoms and history make me a reasonable candidate to discuss this kind of treatment?
2The trial measured outcomes using the CAPS, which assesses PTSD symptom severity, as well as the WHODAS for day-to-day functioning and the QIDS SR-16 for depression — based on what's been published from this completed study, did TMS show meaningful improvements across all three of those areas, or were some outcomes stronger than others?
3Since this trial is now completed and listed as Phase NA, meaning it may have been more of a feasibility or pilot study rather than a large randomized trial, how confident are you in the safety and effectiveness evidence it produced, and would you consider the findings strong enough to inform a treatment decision for me?
4Are there standard PTSD treatments — like Prolonged Exposure therapy or medication — that I should try first before considering TMS, or does what's been learned from this trial suggest TMS might be worth discussing as an earlier option in my care?
5This trial was specifically conducted in veterans with PTSD, so how relevant do you think its results are to my own situation, and are there any TMS programs currently available that I could access based on what this research found?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.