Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable schizophrenia

Timeline

Completed

Started Nov 2020

Geographic Reach

2 countries

3 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

First Submitted

Initial submission to the registry

May 5, 2020

Completed

1 month until next milestone

First Posted

Study publicly available on registry

June 5, 2020

Completed

6 months until next milestone

Study Start

First participant enrolled

November 30, 2020

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2023

Completed

Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

2.2 years

First QC Date

May 5, 2020

Last Update Submit

October 16, 2023

Conditions

Schizophrenia Schizoaffective Disorder Schizophreniform Disorders

Outcome Measures

Primary Outcomes (1)

Change in mentalizing brain network functional connectivity
Measured using the empathic accuracy fMRI task
2 weeks

Secondary Outcomes (4)

Treatment Tolerability
2 weeks
Treatment Tolerability
2 weeks
Treatment Tolerability
2 weeks
Treatment Tolerability
2 weeks

Study Arms (3)

Active 10 Hz rTMS

ACTIVE COMPARATOR

Active treatment will be targeted to an intensity that is 120% of the resting motor threshold. Stimulation will be delivered at 10 Hz according to conventional FDA-approved parameters (4 s on and 26 s off; 3000 pulses per session; total duration 37.5 mins) .

Device: Repetitive Transcranial Magnetic Stimulation

Active iTBS

ACTIVE COMPARATOR

Active iTBS will be targeted to an intensity that is 120% of the resting motor threshold. Stimulation will be delivered in triplet 50 Hz bursts, repeated at 5 Hz; 2 seconds on and 8 seconds off; 600 pulses per session; total duration of 3 min 9 seconds.

Device: Repetitive Transcranial Magnetic Stimulation (Intermittent Theta Burst Stimulation)

Sham rTMS

SHAM COMPARATOR

Sham stimulation will be delivered using the same stimulation parameters as either 10 Hz rTMS or iTBS. For both active and sham stimulation, TMS coil positioning for each individual will be optimized by combining participant fMRI data, meta-analytic functional analysis, electric field modelling, and real-time neuronavigation.

Device: Repetitive Transcranial Magnetic Stimulation (Sham)

Interventions

Repetitive Transcranial Magnetic StimulationDEVICE

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)

Active 10 Hz rTMS

Repetitive Transcranial Magnetic Stimulation (Intermittent Theta Burst Stimulation)DEVICE

Active iTBS

Repetitive Transcranial Magnetic Stimulation (Sham)DEVICE

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)

Sham rTMS

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64)

You may qualify if:

Age 18-55 years;
Male or Female;
DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder; other specified psychotic disorder (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.

You may not qualify if:

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 cannabis for mild use). Only participants meeting a 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 (i.e. seizures not due to medication/drugs or due to fever) or physical signs of stroke; any diagnosis of a Central Nervous System (CNS) disorder
Requires a benzodiazepine with a regular dose equivalent to lorazepam 2 mg/day or higher or any anticonvulsant due to the potential of these medications to limit the efficacy of rTMS
Suspected DSM-5 intellectual disability based upon clinical interview and psychosocial history or estimated IQ of \<71
Prior Psychosurgery
Presence of MRI contraindications (e.g. pacemakers)
Pregnancy (self-report)
rTMS treatment in the last 5 years
Non-English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Centre for Addiction and Mental Healthlead
Northwell Healthcollaborator
University of Maryland, Baltimorecollaborator
National Institutes of Health (NIH)collaborator

Study Sites (3)

Maryland Psychiatric Research Centre

Catonsville, Maryland, 21228, United States

Location

The Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

Location

Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

Aristotle Voineskos, MD
Centre for Addiction and Mental Health
PRINCIPAL INVESTIGATOR
Anil Malhotra, MD
The Feinstein Institute for Medical Research, Zucker Hillside Hospital
PRINCIPAL INVESTIGATOR
Robert Buchanan, MD
Maryland Psychiatric Research Centre, University of Maryland
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 5, 2020

First Posted

June 5, 2020

Study Start

November 30, 2020

Primary Completion

February 2, 2023

Study Completion

February 2, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing: Will share

Locations

CA(1)US(2)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

Active 10 Hz rTMS

Active iTBS

Sham rTMS

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations