RECRUITING

Targeting the Default Mode Network: A TMS-fMRI Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

In post-traumatic stress disorder (PTSD), intrusive, traumatic, autobiographical memories lead to anxiety symptoms. Recent work suggests a new repetitive pulse transcranial magnetic stimulation (rTMS) brain target that might bring relief. Since this proposed target is not well understood, the goal of the study is to use functional magnetic resonance imaging (fMRI) to identify the brain regions and networks that change with rTMS stimulation at this target area in PTSD patients. Ultimately, this would lead to a personalized approach to rTMS treatment of PTSD based on brain imaging that can be used in a future clinical trial. Participants will be asked to complete psychological testing and questionnaires as well as an initial MRI and two separate TMS-fMRI sessions. Total participation time across all visits is estimated to be five to six hours. Research participation will take place at VA Palo Alto as well as at Stanford University.

Official Title

Targeting the Default Mode Network: A TMS-fMRI Study

Quick Facts

Study Start:2023-08-02
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05646732

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between 18 and 55 years of age
  2. * Ability to maintain a Motor Threshold (MT) with single pulse TMS
  3. * Ability to safely and comfortably undergo an MRI and TMS
  4. * Able to read, verbalize, understand, and voluntarily sign the Informed Consent Form prior to participating in any study-specific procedures or assessments.
  5. * PTSD diagnosis according to the DSM 5, as determined by the Clinician administered PTSD scale (CAPS-5) criteria.
  6. * Commitment to maintaining a stable medication regimen between the two fMRI sessions
  1. * Inability to safely and comfortably undergo an MRI. MRI safety will be determined by the center where MRI's are collected.
  2. * Inability to safely and comfortably undergo TMS. TMS exclusions include any history or condition that puts patients at risk.
  3. * Significant dementia as determined by the Montreal Cognitive Assessments (MoCA)
  4. * 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.
  5. * Being in urgent need of care that would make participation impossible
  6. * Currently taking medications that increase the risk of seizure or influence hemodynamic response
  7. * Presence of any other condition that has the potential to prevent study completion and/or have a confounding effect on the interpretation of results.

Contacts and Locations

Study Contact

James Lavacot, BA
CONTACT
6504935000
james.lavacot@va.gov

Principal Investigator

Allyson C Rosen, Ph.D.
PRINCIPAL_INVESTIGATOR
PAVIR/Palo Alto VAHCS/Stanford University

Study Locations (Sites)

VA Palo Alto
Palo Alto, California, 94304
United States

Collaborators and Investigators

Sponsor: Allyson Rosen

  • Allyson C Rosen, Ph.D., PRINCIPAL_INVESTIGATOR, PAVIR/Palo Alto VAHCS/Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-02
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2023-08-02
Study Completion Date2025-01-31

Terms related to this study

Keywords Provided by Researchers

  • Transcranial Magnetic Stimulation
  • TMS
  • Magnetic Resonance Imaging
  • MRI
  • fMRI
  • TMS-fMRI

Additional Relevant MeSH Terms

  • Post Traumatic Stress Disorder
  • PTSD