Actively Recruiting
iTBS to Enhance Social Cognition in People With Psychosis
Led by Northwell Health · Updated on 2025-05-22
100
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
Sponsors
N
Northwell Health
Lead Sponsor
W
Wellcome Trust
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to examine if iTBS applied to the DMPFC improves social cognitive performance compared to sham stimulation in people diagnosed with schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified. The main objectives of this trial are: * Compare changes in social cognitive performance between the active vs. sham treatment groups * Compare changes in social cognitive network functional connectivity between the active vs. sham treatment groups Each participant will receive iTBS (active or sham) five days per week for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at pre-treatment, post-treatment, and 6 months after the completion of treatment.
CONDITIONS
Official Title
iTBS to Enhance Social Cognition in People With Psychosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 39 years
- Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified confirmed by SCID-5
- On antipsychotic medication for at least 60 days with a stable dose for 30 days prior to study entry
- Able to provide informed consent voluntarily
You will not qualify if you...
- History of substance use disorder (except cannabis, caffeine, or tobacco) within the past 6 months or positive baseline drug screen; moderate to severe cannabis use disorder excluded
- Type 1 diabetes mellitus with early onset or ketoacidosis history
- Acute or unstable medical illnesses that could affect schizophrenia treatment or increase risk
- Neurological diseases with extrapyramidal symptoms, epilepsy with recent grand mal seizures, stroke history, or other CNS disorders
- Requires benzodiazepines at doses equivalent to lorazepam 2 mg/day or higher
- Suspected intellectual disability based on clinical interview and history
- Prior psychosurgery
- Contraindications to MRI (e.g., pacemaker)
- Pregnancy
- Received TMS treatment in the past 3 months
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004
Actively Recruiting
Research Team
A
Andrea Joanlanne
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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