Transcranial Magnetic Stimulation for PTSD

Overseen By Julian Sewall

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: White River Junction Veterans Affairs Medical Center

Must not be taking: Clozapine, Bupropion

Disqualifiers: Pregnancy, CNS disorder, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 2-4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

With this research we 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. If you decide to join this study, you 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, you will be asked to give two breath and blood samples to look for general signs of inflammation.

Who Is on the Research Team?

Bradley Watts

Principal Investigator

US Department of Veterans Affairs

Are You a Good Fit for This Trial?

This trial is for veterans aged 19-70 with moderate to severe PTSD who are eligible for VA healthcare. Participants must agree to audio-recorded assessments, be able to use the TMS device, and if female of childbearing potential, must use birth control. They should also understand and sign consent.

Inclusion Criteria

Agree to have CAPS audio recorded

Ability to obtain a Motor Threshold using the TMS device during screening

Moderate to severe PTSD as determined by a total score of at least 25 on the CAPS within 7 days of randomization

Exclusion Criteria

Current psychosis or mania

Unstable medical conditions

Current alcohol or substance use disorder (except nicotine) that interferes with the patient's ability to participate

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ten rTMS treatments over 2-4 weeks, including fMRI scans and breath and blood samples for inflammation analysis

2-4 weeks

10 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments of PTSD and depressive symptoms

8-10 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation

Trial Overview

The study tests how Transcranial Magnetic Stimulation (rTMS) affects PTSD symptoms by changing brain function and reducing inflammation. It involves ten rTMS sessions over 2-4 weeks, fMRI brain scans, and providing breath and blood samples for inflammation markers.

How Is the Trial Designed?

Group I: Participants receiving open label trial of TMS Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

White River Junction Veterans Affairs Medical Center

Lead Sponsor

Trials

32

Recruited

17,900+