Targeting the Default Mode Network: A TMS-fMRI Study

Part of paid clinical trials in Palo Alto, California.

Sponsor
Allyson Rosen
Study ID
NCT05646732
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • TMS-fMRI — DEVICE
    Participants will undergo simultaneous TMS and fMRI

Study Details

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.

Key Dates

Start date
Aug 2, 2023
Status verified
Apr 2024
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • 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.

Primary Outcome Measure

Resting-State fMRI Connectivity [ Time Frame: During the resting state fMRI (rsfMRI) session ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Palo AltoPalo AltoCalifornia94304
James Lavacot, BA
650-493-5000
Allyson C Rosen, PhD
650-512-3094
Allyson C Rosen, PhD (PRINCIPAL_INVESTIGATOR)

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