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Behavioural Intervention
Transcranial Magnetic Stimulation for Schizophrenia
N/A
Recruiting
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
DSM-V diagnosis of schizophrenia spectrum disorders
Male or female subjects 18 to 40 years of age
Must not have
Lifetime diagnosis of ataxia or other cerebellar disorders
Seizure history
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of 2nd week and 4th week
Summary
This trial is investigating the effects of 4-week rTMS treatment on brain and cognitive functions in patients with schizophrenia. Subjects will be randomized to receive either active or sham rTMS. fMRI scans, clinical assessments, and cognitive tests will be performed at baseline, end of the 2nd week, and end of the 4th week.
Who is the study for?
This trial is for individuals aged 18-40 with a diagnosis of schizophrenia spectrum disorders. It's not suitable for those with cerebellar disorders, recent TMS or ECT treatments, MRI contraindications, active medical conditions affecting cognition, substance abuse within six months, seizure history, or other major psychiatric or neurodegenerative diagnoses.
What is being tested?
The study tests the impact of Transcranial Magnetic Stimulation (rTMS) on brain and cognitive functions in schizophrenia patients over four weeks. Participants will either receive real rTMS plus standard care or sham rTMS (a placebo-like procedure) plus standard care to compare effects.
What are the potential side effects?
Possible side effects from rTMS may include discomfort at the stimulation site, headache, lightheadedness, seizures (very rare), and hearing changes if ear protection isn't used during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a schizophrenia spectrum disorder.
Select...
I am between 18 and 40 years old.
Select...
I understand and can agree to the study's procedures and risks.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with ataxia or another disorder affecting my balance and coordination.
Select...
I have a history of seizures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ end of 2nd week and 4th week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of 2nd week and 4th week
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cerebellar function
Secondary study objectives
Cognitive function
Other study objectives
Cerebellum-cognition associations
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: TMSExperimental Treatment1 Intervention
Group II: ShamPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation
2017
Completed Phase 4
~730
Find a Location
Who is running the clinical trial?
Northwell HealthLead Sponsor
474 Previous Clinical Trials
469,100 Total Patients Enrolled
28 Trials studying Schizophrenia
4,408 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with ataxia or another disorder affecting my balance and coordination.I have been diagnosed with a schizophrenia spectrum disorder.I am between 18 and 40 years old.I understand and can agree to the study's procedures and risks.I have a history of seizures.I have not had TMS in the last 3 months or ECT in the last 6 months.I do not have any health conditions that affect my thinking or how I might respond to treatment.
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.
Research Study Groups:
This trial has the following groups:- Group 1: TMS
- Group 2: Sham
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