Targeting the Default Mode Network: A TMS-fMRI Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
United States
California
VA Palo Alto
RECRUITING
Palo Alto
Contact Information
Primary
James Lavacot, BA
james.lavacot@va.gov
6504935000
Time Frame
Start Date: 2023-08-02
Estimated Completion Date: 2025-01-31
Participants
Target number of participants: 30
Treatments
Experimental: TMS-fMRI
Participants will undergo simultaneous TMS-fMRI as part of this study. There will be two locations stimulated: one control region and one target region. Participants will be randomized with respect to the order of receiving stimulation at the locations, but all participants will receive stimulation at both locations as part of the study. All participants will be considered as one group but order effects will be evaluated as an explanatory variable.
Related Therapeutic Areas
Sponsors
Leads: Allyson Rosen
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov

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