Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study

Conditions
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Schizophrenia, Cerebellar Function, Condition

Intervention / Treatment
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* Device: Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects 18 to 40 years of age DSM-V diagnosis of schizophrenia spectrum disorders Competent to provide informed consent Exclusion Criteria: Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders Lifetime diagnosis of ataxia or other cerebellar disorders Lifetime diagnosis of mental retardation, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, or other neurodegenerative disorders Any active general medical condition or CNS disease which can affect cognition or response to treatment Substance dependence or abuse in the past six months Seizure history TMS within three months or ECT within six months Pregnancy as indicated by self-report MRI contraindications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TMS<br> | Device: Transcranial Magnetic Stimulation<br>* 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.<br>|
| Sham Comparator: Sham<br> | Device: Transcranial Magnetic Stimulation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebellar function | Changes of cerebellar connectivity after TMS treatment compared with baseline, as measured by functional magnetic resonance imaging (fMRI) | end of 2nd week and 4th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive function | Changes of scores for the Brief Assessment of Cognition in Schizophrenia (BACS) battery after TMS treatment compared with baseline | end of 2nd week and 4th week |