iTBS to Enhance Social Cognition in People With Psychosis

Last updated: May 19, 2025
Sponsor: Northwell Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Tourette's Syndrome

Affective Disorders

Schizophrenia And Schizoaffective Disorders (Pediatric)

Treatment

iTBS (Active)

iTBS (Sham)

Clinical Study ID

NCT06118268
23-0071
  • Ages 18-39
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-39 years.

  2. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniformdisorder, or psychotic disorder not otherwise specified (documented by SCID-5).

  3. Prescription of antipsychotic medication for at least 60 days and constant dose for 30 days prior to study entry (either first- or second-generation antipsychoticspermitted).

  4. Able to participate in the informed consent process and provide voluntary informedconsent.

Exclusion

Exclusion Criteria:

  1. A history of a DSM-5 substance use disorder (other than cannabis, caffeine, ortobacco) within the past six months; or a positive baseline urine drug screen. Onlyparticipants meeting for moderate to severe cannabis use disorder will be excluded.

  2. Type 1 diabetes mellitus (i.e., insulin-dependent diabetes mellitus with onset < 35years of age and/or diabetes mellitus that has been complicated by a priordocumented episode of ketoacidosis)

  3. Acute or unstable medical illness (e.g., delirium, cancer, uncontrolled diabetes,decompensated cardiac, hepatic, renal or pulmonary disease, stroke, or myocardialinfarction), whose pathology or treatment could alter the presentation or treatmentof schizophrenia or significantly increase the risk associated with the proposedtreatment protocol

  4. Neurological disease associated with extrapyramidal signs and symptoms (e.g.,Parkinson's disease); epilepsy, if the person has had one or more grand mal seizuresin the past 18 months; history or physical signs of stroke; any diagnosis of aCentral Nervous System (CNS) disorder

  5. Requires a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher dueto the potential of these medications to limit the efficacy of iTBS

  6. Suspected DSM-5 intellectual disability based upon clinical interview andpsychosocial history

  7. Prior Psychosurgery

  8. Presence of MRI contraindications (e.g., pacemakers)

  9. Pregnancy

  10. TMS treatment in the past three months

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: iTBS (Active)
Phase:
Study Start date:
April 18, 2023
Estimated Completion Date:
April 30, 2027

Connect with a study center

  • Zucker Hillside Hospital

    Glen Oaks, New York 11004
    United States

    Active - Recruiting

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