Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Recruiting · NCT05389787 · Interventional (participants receive a specific treatment) · Lead sponsor: Northwell Health
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- Zucker Hillside Hospital - New York, New York, United States