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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 belowSelect...
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:Select...
I have wounds or infections on my scalp.
Select...
I have a neurological disorder.
Select...
I am currently experiencing seizures.
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
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 moreSecondary 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
2,585 Previous Clinical Trials
15,084,029 Total Patients Enrolled
17 Trials studying Schizophrenia
1,736 Patients Enrolled for Schizophrenia
National Institute of Mental Health (NIMH)NIH
2,915 Previous Clinical Trials
2,738,595 Total Patients Enrolled
254 Trials studying Schizophrenia
89,871 Patients Enrolled for Schizophrenia
Karuna Subramaniam, PhDPrincipal InvestigatorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have undergone an MRI scan and the results meet the requirements for the study.I have wounds or infections on my scalp.You are not currently struggling with addiction to alcohol or drugs.You are afraid of being in small spaces and cannot undergo an MRI.You have metal implants or electronic devices inside your body.I am in good overall health.I have a neurological disorder.I've been stable as an outpatient for 12 weeks and on a low to moderate dose of antipsychotic medication.I have been diagnosed with schizophrenia.English is my first language.I do not have a neurological disorder.I am currently experiencing seizures.
Research Study Groups:
This trial has the following groups:- Group 1: Medial/Superior Prefrontal TMS
- Group 2: Posterior Parietal TMS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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