Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Study Details
Study Description
Brief Summary
This is a single-site, sham-controlled, randomized trial in a total of 60 subjects between ages 18 and 40 years with schizophrenia. This study will investigate the effects of 4-week rTMS treatment on brain and cognitive functions in patients. Subjects will be randomized to one of the following arms:
Arm 1: Standard of Care (SOC) and active rTMS Arm 2: Standard of Care (SOC) and sham rTMS
Each participant will receive rTMS five days per week, for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at baseline, end of the 2nd week, and end of the 4th week.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: TMS
|
Device: Transcranial Magnetic Stimulation
The TMS will be administrated using the MagVenture Mag Pro R30 device equipped with a B-70 coil. The FDA-approved iTBS sequence will be applied: 10 bursts of three biphasic pulses at 50 Hz, repeated at 5 Hz, for 10 seconds for a total of 600 pulses, and will be repeated for three times. The total stimulation time is ~10 min per session (day). Patients will receive five sessions (days) of rTMS each week, and the total treatment will last for four weeks.
|
| Sham Comparator: Sham
|
Device: Transcranial Magnetic Stimulation
The TMS will be administrated using the MagVenture Mag Pro R30 device equipped with a B-70 coil. The FDA-approved iTBS sequence will be applied: 10 bursts of three biphasic pulses at 50 Hz, repeated at 5 Hz, for 10 seconds for a total of 600 pulses, and will be repeated for three times. The total stimulation time is ~10 min per session (day). Patients will receive five sessions (days) of rTMS each week, and the total treatment will last for four weeks.
|
Outcome Measures
Primary Outcome Measures
- Cerebellar function [end of 2nd week and 4th week]
Changes of cerebellar connectivity after TMS treatment compared with baseline, as measured by functional magnetic resonance imaging (fMRI)
Secondary Outcome Measures
- Cognitive function [end of 2nd week and 4th week]
Changes of scores for the Brief Assessment of Cognition in Schizophrenia (BACS) battery after TMS treatment compared with baseline
Other Outcome Measures
- Cerebellum-cognition associations [end of 2nd week and 4th week]
Pearson Correlations between changes of cerebellar connectivity (as measured by fMRI) and changes of cognitive scores (as measured by BACS)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female subjects 18 to 40 years of age
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DSM-V diagnosis of schizophrenia spectrum disorders
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Competent to provide informed consent
Exclusion Criteria:
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Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders
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Lifetime diagnosis of ataxia or other cerebellar disorders
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Lifetime diagnosis of mental retardation, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, or other neurodegenerative disorders
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Any active general medical condition or CNS disease which can affect cognition or response to treatment
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Substance dependence or abuse in the past six months
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Seizure history
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TMS within three months or ECT within six months
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Pregnancy as indicated by self-report
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MRI contraindications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Zucker Hillside Hospital | New York | New York | United States | 11004 |
Sponsors and Collaborators
- Northwell Health
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 22-0171