Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Part of paid clinical trials in New York, New York.
- Sponsor
- Northwell Health
- Study ID
- NCT05389787
- Status
- Recruiting
Conditions
- Cerebellar Function
- Condition
- Schizophrenia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 60 Years
- Healthy Volunteers
- Not accepted
Interventions
- Transcranial Magnetic Stimulation — DEVICEThe 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.
Study Details
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.
Key Dates
- Start date
- Aug 18, 2022
- Status verified
- Sep 2025
- Primary completion
- Aug 31, 2027
- Completion
- Aug 31, 2027
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- FACTORIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: TMS
- Sham Comparator: Sham
Primary Outcome Measure
Cerebellar function [ Time Frame: end of 2nd week and 4th week ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Zucker Hillside Hospital | New York | New York | 11004 |
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