Neuromodulation of Social Cognitive Circuitry in People With Schizophrenia Spectrum Disorders

Last updated: October 16, 2023
Sponsor: Centre for Addiction and Mental Health
Overall Status: Completed

Phase

N/A

Condition

Tourette's Syndrome

Schizophrenia And Schizoaffective Disorders

Mood Disorders

Treatment

Repetitive Transcranial Magnetic Stimulation (Intermittent Theta Burst Stimulation)

Repetitive Transcranial Magnetic Stimulation (Sham)

Repetitive Transcranial Magnetic Stimulation

Clinical Study ID

NCT04418011
133/2019
  • Ages 18-55
  • All Genders

Study Summary

In this study, the investigators will be examining the effects of repetitive transcranial magnetic stimulation (rTMS) and intermittent theta burst stimulation (iTBS) on social cognitive impairments in individuals with schizophrenia spectrum disorders. Participants will be chosen by chance to receive either active rTMS stimulation, active iTBS stimulation, sham rTMS, or sham iTBS. The investigators predict that active 10Hz and iTBS stimulation will improve social cognitive impairments compared to sham stimulation. We aim to identify which type of active stimulation is most effective at inducing changes social cognition brain circuitry and secondarily which type of active stimulation is best tolerated and most effective at inducing changes in social cognitive performance.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-55 years;
  2. Male or Female;
  3. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or schizophreniformdisorder; other specified psychotic disorder (documented by SCID-5);
  4. Prescription of antipsychotic medication for at least 60 days and constant dose for 30days prior to study entry (either first or second generation antipsychoticspermitted);
  5. Able to participate in the informed consent process and provide voluntary informedconsent.

Exclusion

Exclusion Criteria:

  1. DSM-5 substance use disorder (other than caffeine, mild cannabis use, or tobacco)within the past six months; or a positive baseline urine drug screen (except cannabisfor mild use). Only participants meeting a moderate to severe cannabis use disorderwill be excluded
  2. Type 1 diabetes mellitus (i.e., insulin-dependent diabetes mellitus with onset < 35years of age and/or diabetes mellitus that has been complicated by a prior documentedepisode of ketoacidosis)
  3. Acute or unstable medical illness (e.g. delirium, cancer, uncontrolled diabetes,decompensated cardiac, hepatic, renal or pulmonary disease, stroke, or myocardialinfarction), whose pathology or treatment could alter the presentation or treatment ofschizophrenia or significantly increase the risk associated with the proposedtreatment protocol
  4. Neurological disease associated with extrapyramidal signs and symptoms (e.g.Parkinson's disease); epilepsy (i.e. seizures not due to medication/drugs or due tofever) or physical signs of stroke; any diagnosis of a Central Nervous System (CNS)disorder
  5. Requires a benzodiazepine with a regular dose equivalent to lorazepam 2 mg/day orhigher or any anticonvulsant due to the potential of these medications to limit theefficacy of rTMS
  6. Suspected DSM-5 intellectual disability based upon clinical interview and psychosocialhistory or estimated IQ of <71
  7. Prior Psychosurgery
  8. Presence of MRI contraindications (e.g. pacemakers)
  9. Pregnancy (self-report)
  10. rTMS treatment in the last 5 years
  11. Non-English speakers

Study Design

Total Participants: 70
Treatment Group(s): 3
Primary Treatment: Repetitive Transcranial Magnetic Stimulation (Intermittent Theta Burst Stimulation)
Phase:
Study Start date:
November 30, 2020
Estimated Completion Date:
February 02, 2023

Study Description

This study is a randomized, double blind, sham controlled study which aims to use repetitive transcranial magnetic stimulation (rTMS), a form of neuromodulation, to target the neural circuitry of social cognitive (SCog) impairments in people with Schizophrenia Spectrum Disorders. We will randomize 60 people with SSDs to three groups: 20 to a conventional form of rTMS (i.e. 10 Hz rTMS); 20 to intermittent theta burst stimulation (iTBS); and 20 to either sham 10Hz rTMS stimulation or sham iTBS. We will determine whether these treatments can change the functional connectivity of key SCog brain circuits by targeting a brain region known as the dorsomedial prefrontal cortex (DMPFC). Since each person's anatomical and functional brain profile is slightly different, we will optimize the orientation and location of coil placement in each individual. Overall, our proposal follows a target engagement framework, including specifics regarding testing brain stimulation parameters (i.e., rTMS vs. iTBS) and individualizing coil placement for optimal targeting. We anticipate that active 10 Hz rTMS or iTBS will demonstrate target engagement compared to sham, and potentially ameliorate SCog deficits in people with SSDs. Our primary goal is to identify which treatment best induces change in SCog brain circuitry and secondarily which treatment is best tolerated and induces changes in social cognitive performance.

Connect with a study center

  • Centre for Addiction and Mental Health

    Toronto, Ontario
    Canada

    Site Not Available

  • Maryland Psychiatric Research Centre

    Catonsville, Maryland 21228
    United States

    Site Not Available

  • The Feinstein Institute for Medical Research

    Manhasset, New York 11030
    United States

    Site Not Available

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