iSCIP: iTBS to Enhance Social Cognition in People With Psychosis

Sponsor

Northwell Health (Other)

Overall Status

Recruiting

CT.gov ID

NCT06118268

Collaborator

Wellcome Trust (Other), Centre for Addiction and Mental Health (Other), University of Maryland, Baltimore (Other)

100

Enrollment

Location

Arms

47.4

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Schizo Affective Disorder Schizophreniform Disorders Psychosis Nos/Other	Device: iTBS (Active) Device: iTBS (Sham)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

iTBS to Enhance Social Cognition in People With Psychosis

Actual Study Start Date :

Apr 18, 2023

Anticipated Primary Completion Date :

Apr 1, 2027

Anticipated Study Completion Date :

Apr 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Active iTBS	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).
Sham Comparator: Sham iTBS	Device: 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).

Arm

Intervention/Treatment

Active Comparator: Active iTBS

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).

Sham Comparator: Sham iTBS

Device: 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).

Outcome Measures

Primary Outcome Measures

Change in social cognitive performance [From baseline to 4 weeks]
Measured using the emotion recognition (ER-40) task
Change in social cognitive performance [From baseline to 4 weeks]
Measured using the reading the mind in the eyes (RMET) task
Change in social cognitive performance [From baseline to 4 weeks]
Measured using the test of the awareness of social inference-revised (TASIT-R)

Secondary Outcome Measures

Change in social cognitive network functional connectivity [From baseline to 4 weeks]
Measured using the empathic accuracy fMRI task

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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