RecruitingNot ApplicableNCT06118268

iTBS to Enhance Social Cognition in People With Psychosis

Sponsor

Northwell Health

Enrollment

100 participants

Start Date

Apr 18, 2023

Study Type

INTERVENTIONAL

Conditions

Schizophrenia Schizo Affective Disorder Schizophreniform Disorders Psychosis Nos/Other

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study tests intermittent theta burst stimulation (iTBS) — a non-invasive form of brain stimulation — to improve social cognition in people with psychosis. Social cognition means the ability to understand emotions, read facial expressions, and navigate social situations, which is often impaired in schizophrenia. **You may be eligible if:** - You are between 18 and 39 years old - You have a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or a related psychotic disorder (confirmed by a structured clinical interview) - You have been on a stable antipsychotic medication dose for at least 30 days **You may NOT be eligible if:** - You have a substance use disorder (other than cannabis, caffeine, or tobacco) in the past year - You have a history of seizures or have a metal implant in your head that would make brain stimulation unsafe - You have certain neurological conditions - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEiTBS (Active)

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).

DEVICEiTBS (Sham)

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).