Using brain imaging to improve treatment for PTSD with TMS
Targeting the Default Mode Network: A TMS-fMRI Study
This study is testing if brain scans can help improve a treatment called rTMS for people with PTSD by finding out how it affects their brain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Palo Alto Veterans Institute for Research Academic / other |
| Locations | 1 site (Palo Alto, California) |
| Trial ID | NCT05646732 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on the default mode network (DMN) in patients with post-traumatic stress disorder (PTSD). By utilizing functional magnetic resonance imaging (fMRI), researchers aim to identify brain regions that change in response to rTMS, potentially leading to a personalized treatment approach for PTSD. Participants will undergo psychological assessments, MRI scans, and two TMS-fMRI sessions, with a total participation time of five to six hours. The study is conducted at VA Palo Alto and Stanford University.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 55 with a primary diagnosis of PTSD who can safely undergo MRI and TMS procedures.
Not a fit: Patients with significant dementia or those unable to safely undergo MRI or TMS will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, personalized treatments for PTSD, improving patient outcomes.
How similar studies have performed: While there have been studies targeting the DMN in other conditions, this specific approach using rTMS in PTSD is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 18 and 55 years of age * Ability to maintain a Motor Threshold (MT) with single pulse TMS * Ability to safely and comfortably undergo an MRI and TMS * Able to read, verbalize, understand, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments. * PTSD diagnosis according to the DSM 5, as determined by the Clinician administered PTSD scale (CAPS-5) criteria. * Commitment to maintaining a stable medication regimen between the two fMRI sessions Exclusion Criteria: * Inability to safely and comfortably undergo an MRI. MRI safety will be determined by the center where MRI's are collected. * Inability to safely and comfortably undergo TMS. TMS exclusions include any history or condition that puts patients at risk. * Significant dementia as determined by the Montreal Cognitive Assessments (MoCA) * Common comorbid disorders of Veterans are allowed, but PTSD must be a primary diagnosis causing significant impairment that could not be accounted for by another diagnosis. Medical or mental health conditions that interact with or confound interpretation of PTSD symptoms and anxiety would be exclusionary. * Being in urgent need of care that would make participation impossible * Currently taking medications that increase the risk of seizure or influence hemodynamic response * Presence of any other condition that has the potential to prevent study completion and/or have a confounding effect on the interpretation of results.
Where this trial is running
Palo Alto, California
- VA Palo Alto — Palo Alto, California, United States (Recruiting)
Study contacts
- Principal investigator: Allyson C Rosen, Ph.D. — PAVIR/Palo Alto VAHCS/Stanford University
- Study coordinator: James Lavacot, BA
- Email: james.lavacot@va.gov
- Phone: 6504935000
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.