Neuromodulation of Social Cognitive Circuitry in People With Schizophrenia Spectrum Disorders

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.

Conditions

• Schizophrenia
• Schizoaffective Disorder
• Schizophreniform Disorders

Interventions

DEVICE

Repetitive Transcranial Magnetic Stimulation

The present study aims to use both repetitive transcranial magnetic stimulation (rTMS) and intermittent theta burst stimulation (iTBS), safe and effective forms of neuromodulation, to target the neural circuitry of social cognitive (SCog) impairments in people with SSDs. Treatment sessions will be administered five days per week for two weeks. Other Name: MagPro X100 or R30 (Medtronic A/S. Copenhagen, Denmark) equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Brainsight neuronavigation system (Rogue Resolutions, Montreal, Canada) or Localite (Localite GmbH, Bonn, Germany)

DEVICE

Repetitive Transcranial Magnetic Stimulation (Intermittent Theta Burst Stimulation)

The present study aims to use both repetitive transcranial magnetic stimulation (rTMS) and intermittent theta burst stimulation (iTBS), safe and effective forms of neuromodulation, to target the neural circuitry of social cognitive (SCog) impairments in people with SSDs. Treatment sessions will be administered five days per week for two weeks. Other Name: MagPro X100 or R30 (Medtronic A/S. Copenhagen, Denmark) equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Brainsight neuronavigation system (Rogue Resolutions, Montreal, Canada) or Localite (Localite GmbH, Bonn, Germany)

DEVICE

Repetitive Transcranial Magnetic Stimulation (Sham)

Other Name: MagPro X100 or R30(Medtronic A/S. Copenhagen, Denmark) equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Brainsight neuronavigation system (Rogue Resolutions, Montreal, Canada) or Localite (Localite GmbH, Bonn, Germany)

Sponsors & Collaborators

• Northwell Health

  collaborator OTHER

• University of Maryland, Baltimore

  collaborator OTHER

• National Institutes of Health (NIH)

  collaborator NIH

• Centre for Addiction and Mental Health

  lead OTHER

Principal Investigators

• Aristotle Voineskos, MD · Centre for Addiction and Mental Health

• Anil Malhotra, MD · The Feinstein Institute for Medical Research, Zucker Hillside Hospital

• Robert Buchanan, MD · Maryland Psychiatric Research Centre, University of Maryland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-30

Primary Completion

2023-02-02

Completion

2023-02-02

FDA Device

Yes

Countries

• United States
• Canada

Study Locations