Recruiting

iTBS

Sponsor:

Northwell Health

Code:

NCT06118268

Conditions

Schizophrenia

Schizo Affective Disorder

Schizophreniform Disorders

Psychosis Nos/Other

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Interventions

iTBS (Active)

iTBS (Sham)

Study Details

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

Study ID

NCT06118268

Start date

Apr 18, 2023

Status verified date

May, 2025

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18-39 years.
2. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, 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 antipsychotics permitted).
4. Able to participate in the informed consent process and provide voluntary informed consent.

Exclusion Criteria:

1. 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.
2. 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)
3. 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
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 seizures in the past 18 months; history or physical signs of stroke; any diagnosis of a Central Nervous System (CNS) disorder
5. 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
6. Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history
7. Prior Psychosurgery
8. Presence of MRI contraindications (e.g., pacemakers)
9. Pregnancy
10. TMS treatment in the past three months

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Active iTBS

sham comparator: Sham iTBS

Interventions

iTBS (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).

iTBS (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).

Primary outcome measure

  • Change in social cognitive performance [ Time Frame: From baseline to 4 weeks ]
  • Change in social cognitive performance [ Time Frame: From baseline to 4 weeks ]
  • Change in social cognitive performance [ Time Frame: From baseline to 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Zucker Hillside Hospital

Recruiting

Glen Oaks, New York, United States, 11004

Contacts

More Information

Sponsor

Northwell Health

Last update posted

May 22, 2025

Last verified

May, 2025

Keywords

  • TMS
  • iTBS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2025-05-22.