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NCT Number: NCT06118268

iTBS to Enhance Social Cognition in People With Psychosis

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location status: Recruiting

Location contact

Andrea Joanlanne

CONTACT

[email protected]

718-470-8898

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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).

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).

Primary outcomes

  1. Change in social cognitive performance

    Time frame: From baseline to 4 weeks

    Measured using the emotion recognition (ER-40) task

  2. Change in social cognitive performance

    Time frame: From baseline to 4 weeks

    Measured using the reading the mind in the eyes (RMET) task

  3. Change in social cognitive performance

    Time frame: From baseline to 4 weeks

    Measured using the test of the awareness of social inference-revised (TASIT-R)

Secondary outcomes

  1. Change in social cognitive network functional connectivity

    Time frame: From baseline to 4 weeks

    Measured using the empathic accuracy fMRI task

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea Joanlanne

CONTACT

[email protected]

718-470-8898

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • Centre for Addiction and Mental Health
  • University of Maryland, Baltimore
  • Wellcome Trust

Registry information

Acronym: iSCIP

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2023
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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