NCT05389787NARecruiting

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

Northwell Health

Start Date

8/18/2022

Completion Date

8/31/2027

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.

Eligibility Criteria

Age Range: 18 years to 60 years

Inclusion Criteria: 1. Male or female subjects 18 to 60 years of age 2. DSM-V diagnosis of schizophrenia spectrum disorders 3. Competent to provide informed consent Exclusion Criteria: 1. Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders 2. Lifetime diagnosis of ataxia or other cerebellar disorders 3. Lifetime diagnosis of mental retardation, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, or other neurodegenerative disorders 4. Any active general medical condition or CNS disease which can affect cognition or response to treatment 5. Substance dependence or abuse in the past six months 6. Seizure history 7. TMS within three months or ECT within six months 8. Pregnancy as indicated by self-report 9. MRI contraindications

Interventions

DEVICE

Transcranial Magnetic Stimulation

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Conditions

SchizophreniaCerebellar FunctionCondition

Locations

Zucker Hillside Hospital

New York, New York 11004

United States