iTBS to Enhance Social Cognition in People With Psychosis

Schizophrenia Clinical Trial

— iSCIP  

Official title:

iTBS to Enhance Social Cognition in People With Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06118268
• Other study ID #: 23-0071
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2023
• Est. completion date: April 2027

Study information

• Verified date: November 2023
• Source: Northwell Health
• Contact: Andrea Joanlanne
• Phone: 718-470-8898
• Email: ajoanlanne[@]northwell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Mood Disorders
• Psychosis Nos/Other
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia
• Schizophreniform Disorders

Intervention

Device:
• 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).

Locations

Country	Name	City	State
United States	Zucker Hillside Hospital	Glen Oaks	New York

Sponsors (4)

Lead Sponsor	Collaborator
Northwell Health	Centre for Addiction and Mental Health, University of Maryland, Baltimore, Wellcome Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in social cognitive performance	Measured using the emotion recognition (ER-40) task	From baseline to 4 weeks
Primary	Change in social cognitive performance	Measured using the reading the mind in the eyes (RMET) task	From baseline to 4 weeks
Primary	Change in social cognitive performance	Measured using the test of the awareness of social inference-revised (TASIT-R)	From baseline to 4 weeks
Secondary	Change in social cognitive network functional connectivity	Measured using the empathic accuracy fMRI task	From baseline to 4 weeks