iTBS to Enhance Social Cognition in People With Psychosis
Part of paid clinical trials in Glen Oaks, New York.
- Sponsor
- Northwell Health
- Study ID
- NCT06118268
- Status
- Recruiting
Conditions
- Psychosis Nos/Other
- Schizo Affective Disorder
- Schizophrenia
- Schizophreniform Disorders
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 39 Years
- Healthy Volunteers
- Not accepted
Interventions
- iTBS (Active) — DEVICEThe present study is a double-blind, randomized clinical trial that will examine if iTBS applied to DMPFC improves social cognitive performance compared to sham stimulation DMPFC-iTBS will be administered using the MagPro R30 stimulator equipped with a Cool-B70 coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Visor 2.0 system (Advanced Neuro Technologies Enschede, Netherlands).
- iTBS (Sham) — DEVICEDMPFC-iTBS will be administered using the MagPro R30 stimulator equipped with a Cool-B70 coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Visor 2.0 system (Advanced Neuro Technologies Enschede, Netherlands).
Study Details
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.
Key Dates
- Start date
- Apr 18, 2023
- Status verified
- May 2025
- Primary completion
- Apr 30, 2027
- Completion
- Apr 30, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Active Comparator: Active iTBS
- Sham Comparator: Sham iTBS
Primary Outcome Measure
Change in social cognitive performance [ Time Frame: From baseline to 4 weeks ]
Central Contacts
- Andrea Joanlanne718-470-8898
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Zucker Hillside Hospital | Glen Oaks | New York | 11004 |
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