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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to immediate and distal time points after tms, up to 4 weeks

Awards & highlights

MESSI Trial 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.Check my eligibility

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.See study design

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.

MESSI Trial 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.

MESSI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to immediate and distal time points after tms, up to 4 weeks

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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)

MESSI 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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,395 Total Patients Enrolled

17 Trials studying Schizophrenia

1,736 Patients Enrolled for Schizophrenia

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,689,607 Total Patients Enrolled

249 Trials studying Schizophrenia

89,275 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment accept volunteers who are over 35 years old?

"Eligible enrollees for this medical trial must fall between 18 and 60 years old. For those aged under 18, there are 46 trials open to them while 164 studies are available for seniors above 65."

Answered by AI

How many participants are enrolling in this medical research project?

"Affirmative. According to clinicaltrials.gov, this medical experiment was initially made public on November 12th 2020 and has since been updated on April 25th 2022. The trial is looking for 160 subjects at a single site of research."

Answered by AI

Is this trial providing subjects with the opportunity to participate?

"Affirmative, clinicaltrials.gov has verified that this research is currently recruiting participants. This experiment was initially posted on November 12th 2020 and the most recent update took place April 25th 2022. The trial requires 160 volunteers from 1 site to participate."

Answered by AI

Are there specific qualifications for enrolment in this research project?

"The prerequisites for this clinical trial include being between 18 and 60 years old, having schizophrenia but no other neurological conditions, abstaining from alcohol or substance use disorder, good overall physical health, 12 weeks of outpatient status prior to enrolment, plus a 4 week period with lower doses of antipsychotic medication (less than 1000 mg. chlorpromazine equivalents) and stable dosages for all other psychotropic medications. Altogether 160 participants are sought after for the duration of this study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Medial-prefrontal Enhancement During Schizophrenia Systems Imaging

2020. "Medial-prefrontal Enhancement During Schizophrenia Systems Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04807530.

All > Schizophrenia