Medial-prefrontal Enhancement During Schizophrenia Systems Imaging
Part of paid clinical trials in San Francisco, California.
- Sponsor
- University of California, San Francisco
- Study ID
- NCT04807530
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 64 Years
- Healthy Volunteers
- Accepted
Interventions
- TMS — DEVICEThe investigators will use the NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM to apply 10 Hz nrTMS to healthy controls (HC) and schizophrenia patients (SZ)
Study Details
This randomized controlled trial in healthy controls (HC) and patients with schizophrenia (SZ) aims to examine 1) the underlying cognitive and neural cause of self-agency deficits in SZ; 2) the responsiveness to a novel navigated repetitive transcranial magnetic stimulation (nrTMS) target in the medial/superior prefrontal cortex (mPFC); and 3) how modulation of mPFC activity impacts the larger self-agency network to mediate changes in self-agency judgments. Our overall hypothesis is that increased mPFC excitability by active high-frequency nrTMS in HC and SZ will induce behavioral improvements in self-agency and neural changes in the larger self-agency network that will generalize to improvements in overall cognition, symptoms and daily functioning, and will likely lead to the development of new effective neuromodulation therapies in patients with schizophrenia.
Key Dates
- Start date
- Nov 12, 2020
- Status verified
- Aug 2025
- Primary completion
- Dec 30, 2026
- Completion
- Dec 30, 2026
Study Design
- Enrollment
- 160 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Medial/Superior Prefrontal TMS10 Hz High frequency TMS applied to the mPFC
- Placebo Comparator: Posterior Parietal TMS10 Hz high frequency TMS applied to the posterior parietal cortex
Primary Outcome Measure
Self-Agency Behavioral Change during Reality Monitoring after TMS vs Baseline (metrics of accuracy) [ Time Frame: From baseline, to immediately after TMS, up to 1 week ]
Central Contacts
- Karuna Subramaniam, Ph.D415-221-4810
- Miriam Mathew, PhD
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCSF | San Francisco | California | 94143 | Miriam Mathew, PhD |
Find similar trials in San Francisco, CA
Related Studies
- Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With SchizophreniaPHASE3 · Recruiting · Gedeon Richter Plc. · Culver City, California
- Imaging Synapses With [11C] UCB-J in the Human BrainPHASE1 · Recruiting · Davidzon, Guido, M.D. · Palo Alto, California
- Effects of Brain Stimulation on Cognition, Oscillations and GABA Levels in SchizophreniaRecruiting · University of California, Davis · Sacramento, California
- Long-term Safety Extension Study of OLZ/SAM in Pediatric SubjectsPHASE3 · Enrolling By Invitation · Alkermes, Inc. · Dothan, Alabama