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| Name | Class |
|---|---|
| Wellcome Trust | OTHER |
| Centre for Addiction and Mental Health | OTHER |
| University of Maryland, Baltimore | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active iTBS | Active Comparator |
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| Sham iTBS | Sham Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iTBS (Active) | Device | The 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in social cognitive performance | Measured using the emotion recognition (ER-40) task | From baseline to 4 weeks |
| Change in social cognitive performance | Measured using the reading the mind in the eyes (RMET) task | From baseline to 4 weeks |
| Change in social cognitive performance | Measured using the test of the awareness of social inference-revised (TASIT-R) | From baseline to 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in social cognitive network functional connectivity | Measured using the empathic accuracy fMRI task | From baseline to 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Joanlanne | Contact | 718-470-8898 | ajoanlanne@northwell.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zucker Hillside Hospital | Recruiting | Glen Oaks | New York | 11004 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| iTBS (Sham) | Device | 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). |
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