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Non-invasive Brain Stimulation
TMS for Schizophrenia
N/A
Recruiting
Led By Xiaoming Du, PhD
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and Female between ages 21-62
Be between 18 and 65 years old
Must not have
Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed
History of head injury with loss of consciousness over 10 minutes; history of brain surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, intermittent (before or at the beginning of treatment visit 11, about 2 weeks after baseline), end of acute treatment (after treatment visit 20, about 4 weeks after baseline)
Summary
This trial is testing whether electrical stimulations to the prefrontal cortex can help reduce symptoms in people with schizophrenia, specifically auditory hallucinations and poor working memory/sustained attention.
Who is the study for?
This trial is for adults aged 21-62 with schizophrenia, stable on their current medication for at least 4 weeks. They must be able to consent and not have a history of seizures, family epilepsy, significant substance abuse recently (except nicotine or marijuana), or take high doses of clozapine. Pregnant women and those with metal implants near the head can't participate.
What is being tested?
The study tests if targeted repetitive TMS (a non-invasive brain stimulation) to the prefrontal cortex can improve symptoms like auditory hallucinations and attention in schizophrenia patients. It compares active rTMS against sham (fake) treatment to see if it corrects abnormal brain activity.
What are the potential side effects?
rTMS may cause discomfort at the stimulation site, headache, lightheadedness, or twitching facial muscles during treatment. Seizures are rare but possible; hence people with seizure history aren't eligible.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 21 and 62 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have a pacemaker, metal implants near my head, or unstable heart disease.
Select...
I have had a head injury with unconsciousness over 10 minutes or brain surgery.
Select...
I have a history of seizures.
Select...
A close family member has epilepsy.
Select...
I do not have any major illnesses affecting my brain function.
Select...
I am taking more than 400 mg of clozapine daily.
Select...
I am pregnant or might be pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, intermittent (before or at the beginning of treatment visit 11, about 2 weeks after baseline), end of acute treatment (after treatment visit 20, about 4 weeks after baseline)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, intermittent (before or at the beginning of treatment visit 11, about 2 weeks after baseline), end of acute treatment (after treatment visit 20, about 4 weeks after baseline)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Brain connectivity as indicated by resting state functional connectivity value as assessed by functional magnetic resonance imaging (fMRI)
Secondary study objectives
Auditory hallucinations as assessed by Psychotic Symptom Rating Scale (PSYRATS)
Cognitive insight as assessed by the Beck Cognitive Insight Scale (BCIS)
Delusion as assessed by the Peters Delusions Inventory (conviction score)
+10 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active rTMS stimulationActive Control1 Intervention
Real active rTMS stimulation.
Group II: Sham rTMS stimulationPlacebo Group1 Intervention
Sham repetitive TMS stimulation.
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,720 Total Patients Enrolled
6 Trials studying Schizophrenia
325 Patients Enrolled for Schizophrenia
University of Maryland, BaltimoreLead Sponsor
716 Previous Clinical Trials
380,932 Total Patients Enrolled
67 Trials studying Schizophrenia
10,117 Patients Enrolled for Schizophrenia
Xiaoming Du, PhDPrincipal InvestigatorThe University of Texas Health Science Center, Houston
3 Previous Clinical Trials
230 Total Patients Enrolled
3 Trials studying Schizophrenia
230 Patients Enrolled for Schizophrenia
L E Hong, MDPrincipal InvestigatorUniversity of Maryland, Baltimore
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures.I do not have a pacemaker, metal implants near my head, or unstable heart disease.I have had a head injury with unconsciousness over 10 minutes or brain surgery.A close family member has epilepsy.I do not have any major illnesses affecting my brain function.I am taking more than 400 mg of clozapine daily.I am pregnant or might be pregnant.I am 21 or older and can sign a consent form.I am between 21 and 62 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Active rTMS stimulation
- Group 2: Sham rTMS stimulation
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.