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Accelerated DMN-Targeted cTBS to Modulate DMN Connectivity

StatusCompleted
PhaseNot applicable
Started2024-09-09
View on ClinicalTrials.gov ↗

Amendment history

2026-09-16
notable
Trial status changed: Enrolling by Invitation → Completed
Primary completion confirmed: January 2026 (last estimated June 2026)
2025-09-03
minor
Study Status, Sponsor/Collaborators, Study Description v1
Study description-355 characters
[...] eople with schizophrenia have at least one cognitive symptom (Srisudha et al. 2022). However, there are no current treatments for cognitive imp [...] ividuals with schizophrenia and their first-degree relatives (Whitfield-Gabrieli et al. 2009) and has been associated with cognitive impairment, positive symptoms, negative symptoms, and nicotine use (Whitfield-Gabrieli and Ford 2012; Brady et al. 2019; Woodward et al. 2016; Pu et al. 2016; Ward, Beermann, et al. 2022). Therefore, DMN connectivity may be a potential biomarker a [...] a burst stimulation (cTBS) is inhibitory. In this protocol, we will use inhib [...] [...]
2025-08-26
minor
Original filing
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.
Trial Details
NCT Number NCT07155096
Lead Sponsor Vanderbilt University Medical Center
Conditions Schizophrenia
Enrollment 37 participants
Start Date 2024-09-09
Primary Completion 2026-01-29 (estimated)
Study Completion 2026-02-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-15