NCT04807530 Medial-prefrontal Enhancement During Schizophrenia Systems Imaging
| NCT ID | NCT04807530 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Francisco |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2020-11-12 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2020-11-12 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: All Subjects: * Good general physical health * English is first language * No neurological disorder * Meets MRI criteria * No current alcohol or substance use disorder Schizophrenia participants: * Schizophrenia diagnosis of any illness duration, * Clinical stability, defined as 12 weeks outpatient status and 4 weeks low to moderate dose of antipsychotic medication (\<1000 mg. chlorpromazine equivalents), plus stable doses of all other psychotropic medications Exclusion Criteria: All Subjects: * Implanted metallic parts of implanted electronic devices * Pregnant or trying to become pregnant * Any condition that would prevent the subject from giving voluntary informed consent * Scalp wounds or infections * Claustrophobia precluding MRI * Ongoing seizures * Neurological disorder
Contact & Investigator
Karuna Subramaniam, PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT04807530 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04807530 currently recruiting?
Yes, NCT04807530 is actively recruiting participants. Contact the research team at karuna.subramaniam@ucsf.edu for enrollment information.
Where is the NCT04807530 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT04807530 clinical trial?
NCT04807530 is sponsored by University of California, San Francisco. The principal investigator is Karuna Subramaniam, PhD at University of California, San Francisco. The trial plans to enroll 160 participants.
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