Accelerated DMN-Targeted cTBS to Modulate DMN Connectivity

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07155096
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Repetitive Transcranial Magnetic Stimulation — DEVICE
    Repetitive Transcranial Magnetic Stimulation (rTMS): Participants will each receive Default Mode Network-targeted continuous theta burst stimulation (cTBS) administered at 100% Active Motor Threshold

Study Details

The central hypothesis is this: DMN connectivity can be modulated with inhibitory cTBS when delivered on an accelerated treatment schedule. This study seeks to provide evidence that accelerated, network-targeted inhibitory stimulation of the DMN leads to both altered network activity and a concomitant behavioral change in cognitive performance in individuals with schizophrenia and schizoaffective disorder. This study will also compare the effect of inhibitory cTBS in healthy individuals, as it may also lead to both altered network activity and a behavioral change in cognitive performance in individuals without schizophrenia or schizoaffective disorder. If successful, this study will have identified a safe, effective, and broadly applicable treatment for cognitive impairment in schizophrenia that has potential for translation into many other psychiatric and neurodevelopmental disorders, such as autism.

Key Dates

Start date
Sep 9, 2024
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Default Mode Network-Targeted cTBS
    All participants receive 5 sessions of active cTBS (600 pulses) to the DMN, with a 30-minute inter-session interval.

Primary Outcome Measure

Functional Connectivity Changes [ Time Frame: From enrollment to the end of MRI, maximum 3 weeks. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt Psychiatric HospitalNashvilleTennessee37212-

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