iTBS to Enhance Social Cognition in People With Psychosis

NCT06118268 | Recruiting FDA Device

• 1 other identifier: 23-0071
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia; Schizo Affective Disorder; Schizophreniform Disorders; Psychosis Nos/Other

Keywords

TMS; iTBS

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (1)

• Change in social cognitive network functional connectivity

  From baseline to 4 weeks

Study Arms (2)

Active iTBS

ACTIVE COMPARATOR

Device: iTBS (Active)

Sham iTBS

SHAM COMPARATOR

Device: iTBS (Sham)

Interventions

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).

Active iTBS

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).

Sham iTBS

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-39 years.
• DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder not otherwise specified (documented by SCID-5).
• Prescription of antipsychotic medication for at least 60 days and constant dose for 30 days prior to study entry (either first- or second-generation antipsychotics permitted).
• Able to participate in the informed consent process and provide voluntary informed consent.

You may not qualify if:

• A history of a DSM-5 substance use disorder (other than cannabis, caffeine, or tobacco) within the past six months; or a positive baseline urine drug screen. Only participants meeting for moderate to severe cannabis use disorder will be excluded.
• Type 1 diabetes mellitus (i.e., insulin-dependent diabetes mellitus with onset \< 35 years of age and/or diabetes mellitus that has been complicated by a prior documented episode of ketoacidosis)
• Acute or unstable medical illness (e.g., delirium, cancer, uncontrolled diabetes, decompensated cardiac, hepatic, renal or pulmonary disease, stroke, or myocardial infarction), whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
• Neurological disease associated with extrapyramidal signs and symptoms (e.g., Parkinson's disease); epilepsy, if the person has had one or more grand mal seizures in the past 18 months; history or physical signs of stroke; any diagnosis of a Central Nervous System (CNS) disorder
• Requires a benzodiazepine with a dose equivalent to lorazepam 2 mg/day or higher due to the potential of these medications to limit the efficacy of iTBS
• Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history
• Prior Psychosurgery
• Presence of MRI contraindications (e.g., pacemakers)
• Pregnancy
• TMS treatment in the past three months

Sponsors & Collaborators

• Northwell Health: lead
• Wellcome Trust: collaborator
• Centre for Addiction and Mental Health: collaborator
• University of Maryland, Baltimore: collaborator

Study Sites (1)

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Andrea Joanlanne

CONTACT

718-470-8898; ajoanlanne@northwell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair Research, Zucker Hillside Hospital

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: November 7, 2023
• Study Start: April 18, 2023
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: May 22, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)