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Targeting the Default Mode Network: A TMS-fMRI Study

Launched by ALLYSON ROSEN · Dec 2, 2022

Trial Information

Current as of January 14, 2025

Recruiting

Keywords

Transcranial Magnetic Stimulation Tms Magnetic Resonance Imaging Mri F Mri Tms F Mri

ClinConnect Summary

This clinical trial, titled "Targeting the Default Mode Network: A TMS-fMRI Study," is exploring a new way to help people with Post-Traumatic Stress Disorder (PTSD). PTSD often causes distressing memories that can lead to anxiety. Researchers want to see if a treatment called repetitive transcranial magnetic stimulation (rTMS) can provide relief by focusing on a specific part of the brain. They will use advanced brain imaging (fMRI) to understand how this treatment affects brain activity in individuals with PTSD. The ultimate goal is to tailor rTMS treatments based on individual brain responses, which could lead to more effective therapies in the future.

If you’re between the ages of 18 and 55 and have a PTSD diagnosis, you may be eligible to participate in this study. Participants will need to complete some psychological tests and questionnaires, along with an MRI scan and two sessions of rTMS combined with fMRI. Overall, the study will take about five to six hours across multiple visits at VA Palo Alto and Stanford University. Participants should be stable on their medication and able to undergo MRI and TMS safely. This research aims to improve treatment options for those suffering from PTSD, and your involvement could help make a difference.

Gender

ALL

Eligibility 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.

Trial Officials

Allyson C Rosen, Ph.D.

Principal Investigator

PAVIR/Palo Alto VAHCS/Stanford University

About Allyson Rosen

Allyson Rosen is a dedicated clinical trial sponsor with a strong commitment to advancing medical research and improving patient outcomes. With extensive experience in the pharmaceutical and biotechnology sectors, Allyson focuses on the design, execution, and management of innovative clinical trials across various therapeutic areas. Her expertise encompasses regulatory compliance, patient recruitment, and data analysis, ensuring that each study adheres to the highest standards of quality and ethical practice. Passionate about fostering collaboration among stakeholders, Allyson Rosen is dedicated to translating scientific findings into tangible benefits for patients and the healthcare community.

Locations

Palo Alto, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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