Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT04807530

Conditions

Schizophrenia

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

TMS

Study Details

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.

Conditions

Schizophrenia

Study ID

NCT04807530

Start date

Nov 12, 2020

Status verified date

Aug, 2025

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Medial/Superior Prefrontal TMS

10 Hz High frequency TMS applied to the mPFC

placebo comparator: Posterior Parietal TMS

10 Hz high frequency TMS applied to the posterior parietal cortex

Interventions

TMS

The investigators will use the NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM to apply 10 Hz nrTMS to healthy controls (HC) and schizophrenia patients (SZ)

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 ]
  • Self-Agency Behavioral Change during Speech Monitoring after TMS vs Baseline (metrics of speech perturbation units) [ Time Frame: From baseline, to immediately after TMS, up to 1 week ]
  • MEGI Neural Activity Change related to Self-Agency during Reality Monitoring after TMS vs Baseline (metrics of neural beta activation units) [ Time Frame: From baseline, to immediately after TMS, up to 1 week ]
  • MEGI Neural Activity Change related to Self-Agency during Speech Monitoring after TMS vs Baseline (metrics of neural beta activation units) [ Time Frame: From baseline, to immediately after TMS, up to 1 week ]

Central Contacts and Locations

Central contacts

Karuna Subramaniam, Ph.D

415-221-4810karuna.subramaniam@ucsf.edu

Miriam Mathew, PhD

miriam.mathew@ucsf.edu

Locations

UCSF

Recruiting

San Francisco, California, United States, 94143

Contacts

Miriam Mathew, PhD

miriam.mathew@ucsf.edu

More Information

Sponsor

University of California, San Francisco

Last update posted

Aug 29, 2025

Last verified

Aug, 2025

Keywords

  • Schizophrenia
  • Transcranial Magnetic Stimulation
  • Prefrontal Cortex
  • Self-Agency
  • Reality Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2025-08-29.