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iTBS to Enhance Social Cognition in People With Psychosis

ConditionsSchizophreniaSchizo Affective DisorderSchizophreniform DisordersPsychosis Nos/Other
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorNorthwell Health

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • iTBS (Active)

    Device

    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)

    Device

    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).

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Active iTBSActive comparator 1 intervention
Group B: Sham iTBSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in social cognitive performance

Measured using the emotion recognition (ER-40) task

Time frame
From baseline to 4 weeks
2

Change in social cognitive performance

Measured using the reading the mind in the eyes (RMET) task

Time frame
From baseline to 4 weeks
3

Change in social cognitive performance

Measured using the test of the awareness of social inference-revised (TASIT-R)

Time frame
From baseline to 4 weeks

Secondary outcomes

1

Change in social cognitive network functional connectivity

Measured using the empathic accuracy fMRI task

Time frame
From baseline to 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Wellcome Trust

Collaborator

Centre for Addiction and Mental Health

Collaborator

University of Maryland, Baltimore

Collaborator

Source ClinicalTrials.gov
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