Fact CheckerSign in

NCT06118268Recruiting

iTBS to Enhance Social Cognition in People With Psychosis

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
4 Oct 2023
Start date
30 Oct 2023
Primary completion date
Apr 2027
Lead sponsor
Northwell Health
NCT number
NCT06118268

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 30 Oct 2023 to the primary completion date, Apr 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • 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
  • Prior Psychosurgery

Other illness

  • 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.
  • 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

Other

  • Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history
  • Presence of MRI contraindications (e.g., pacemakers)
  • Pregnancy
  • TMS treatment in the past three months

Who the study is looking for

  • 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.

Age in the registry: 18 years to 39 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zucker Hillside Hospital
Coordinator of this site? Confirm its status
Glen OaksUnited StatesRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.