Actively Recruiting

Phase Not Applicable
Age: 18Years - 39Years
All Genders
NCT06118268

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

Age: 18Years - 39Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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