Using iTBS to Improve Social Cognition in People with Psychosis
iTBS to Enhance Social Cognition in People With Psychosis
This study is testing whether a new brain stimulation treatment can help people with schizophrenia improve their social skills and thinking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 39 Years |
| Sex | All |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (Glen Oaks, New York) |
| Trial ID | NCT06118268 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of intermittent theta burst stimulation (iTBS) on social cognitive performance in individuals diagnosed with schizophrenia and related disorders. Participants will receive either active or sham iTBS treatment five days a week for four weeks, with assessments including functional MRI scans and cognitive tests conducted before, after, and six months post-treatment. The study aims to compare the changes in social cognition and functional connectivity between the two groups to determine the efficacy of the treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-39 with a DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or related psychotic disorders who have been on stable antipsychotic medication.
Not a fit: Patients with a history of substance use disorders (excluding certain substances), type 1 diabetes, or acute medical illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could enhance social cognitive abilities in patients with psychosis, potentially improving their quality of life.
How similar studies have performed: Other studies using similar approaches with TMS have shown promise in improving cognitive functions, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Glen Oaks, New York
- Zucker Hillside Hospital — Glen Oaks, New York, United States (Recruiting)
Study contacts
- Study coordinator: Andrea Joanlanne
- Email: ajoanlanne@northwell.edu
- Phone: 718-470-8898
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.