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Neuromodulation Therapy

TMS for Schizophrenia (MESSI Trial)

N/A
Recruiting
Led By Karuna Subramaniam, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Schizophrenia diagnosis of any illness duration
No neurological disorder
Must not have
Scalp wounds or infections
Neurological disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to immediate and distal time points after tms, up to 4 weeks

Summary

This trial is examining how well a new treatment - navigated repetitive transcranial magnetic stimulation (nrTMS) - works in people with schizophrenia. They are testing to see if this treatment can improve symptoms and cognitive function.

Who is the study for?
This trial is for English-speaking individuals with schizophrenia who are clinically stable on a low to moderate dose of antipsychotic medication, without neurological disorders or substance use issues. They must be in good physical health and able to undergo MRI scans. Pregnant individuals, those with implanted metal/electronic devices, scalp wounds/infections, ongoing seizures, or severe claustrophobia cannot participate.
What is being tested?
The study tests whether high-frequency transcranial magnetic stimulation (TMS) targeting the medial prefrontal cortex can improve self-agency judgments in people with schizophrenia. It will also assess cognitive improvements and daily functioning as well as potential changes within the brain's self-agency network.
What are the potential side effects?
Potential side effects of TMS may include discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. Most people tolerate TMS well and serious side effects are uncommon.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with schizophrenia.
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I do not have a neurological disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have wounds or infections on my scalp.
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I have a neurological disorder.
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I am currently experiencing seizures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to immediate and distal time points after tms, up to 4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to immediate and distal time points after tms, up to 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MEGI Neural Activity Change related to Self-Agency during Reality Monitoring after TMS vs Baseline (metrics of neural beta activation units)
MEGI Neural Activity Change related to Self-Agency during Speech Monitoring after TMS vs Baseline (metrics of neural beta activation units)
Self-Agency Behavioral Change during Reality Monitoring after TMS vs Baseline (metrics of accuracy)
+1 more
Secondary study objectives
Clinical Symptom Change after TMS vs Baseline (metrics units of severity)
Cognition Change after TMS vs Baseline (metrics units of accuracy and speed of processing)
Daily Functioning Change after TMS vs. Baseline (metrics of functioning)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Medial/Superior Prefrontal TMSActive Control1 Intervention
10 Hz High frequency TMS applied to the mPFC
Group II: Posterior Parietal TMSPlacebo Group1 Intervention
10 Hz high frequency TMS applied to the posterior parietal cortex

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,016 Total Patients Enrolled
17 Trials studying Schizophrenia
1,736 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,918 Previous Clinical Trials
2,739,973 Total Patients Enrolled
254 Trials studying Schizophrenia
89,871 Patients Enrolled for Schizophrenia
Karuna Subramaniam, PhDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Navigated Repetitive Transcranial Magnetic Stimulation (nrTMS) (Neuromodulation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04807530 — N/A
Schizophrenia Research Study Groups: Medial/Superior Prefrontal TMS, Posterior Parietal TMS
Schizophrenia Clinical Trial 2023: Navigated Repetitive Transcranial Magnetic Stimulation (nrTMS) Highlights & Side Effects. Trial Name: NCT04807530 — N/A
Navigated Repetitive Transcranial Magnetic Stimulation (nrTMS) (Neuromodulation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04807530 — N/A
~34 spots leftby Dec 2025
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