Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Northwell Health
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Cerebellar function
Study Overview
Brief Summary
This is a single-site, sham-controlled, randomized trial in a total of 40 subjects between ages 18 and 60 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female subjects 18 to 60 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
Arms & Interventions
Sham
Intervention: Transcranial Magnetic Stimulation (Device)
TMS
Intervention: Transcranial Magnetic Stimulation (Device)
Outcomes
Primary Outcomes
Cerebellar function
Time Frame: 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 Outcomes
- Cognitive function(end of 2nd week and 4th week)
Investigators
Hengyi Cao
Associate Professor
Northwell Health