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Repetitive Transcranial Magnetic Stimulation
rTMS for Schizophrenia
N/A
Recruiting
Led By Xiaoming Du, PhD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how rTMS affects patients with SSD, measuring biomarkers before and after to assess the effects.
Who is the study for?
This trial is for men and women aged 18-65 with schizophrenia-spectrum disorder who can consent to participate. Excluded are those with major medical conditions affecting the brain, high clozapine doses, failed TMS screening, significant head injury or surgery, pregnancy without contraception, metal implants near the head, seizure history, or recent substance abuse.
What is being tested?
The study tests active versus sham (fake) repetitive transcranial magnetic stimulation (rTMS) on patients with schizophrenia. It aims to see how rTMS affects certain biomarkers related to the disorder by comparing results before and after treatment in separate sessions.
What are the potential side effects?
While not explicitly listed here, common side effects of rTMS may include headaches or discomfort at the stimulation site. More serious but rare risks involve seizures or hearing loss if proper ear protection isn't used during treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change of mismatch negativity (MMN) from electroencephalography (EEG) signals by active and sham rTMS
Change of resting-state functional connectivity (rsFC) by active and sham rTMS
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Sham rTMS first and active rTMS secondExperimental Treatment1 Intervention
Participants in this arm will receive sham rTMS in one visit first, then receive active rTMS in another visit.
Group II: Active rTMS first and sham rTMS secondExperimental Treatment1 Intervention
Participants in this arm will receive active rTMS in one visit first, then receive sham rTMS in another visit.
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Who is running the clinical trial?
University of Maryland, BaltimoreLead Sponsor
713 Previous Clinical Trials
379,432 Total Patients Enrolled
67 Trials studying Schizophrenia
10,197 Patients Enrolled for Schizophrenia
Xiaoming Du, PhDPrincipal InvestigatorUniversity of Maryland, Baltimore
3 Previous Clinical Trials
310 Total Patients Enrolled
3 Trials studying Schizophrenia
310 Patients Enrolled for Schizophrenia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of seizures.I do not have any major illnesses affecting my brain function.I am pregnant or might be due to recent unprotected sex.I am between 18 and 65 years old.I am taking more than 400 mg of clozapine daily.I have had a head injury with unconsciousness over 10 minutes or brain surgery.I am 18 or older and can sign a consent form.I do not have any non-removable metal objects in or near my head, or unstable heart conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Sham rTMS first and active rTMS second
- Group 2: Active rTMS first and sham rTMS second
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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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