NCT05389787

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Northwell Health · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia
• Cerebellar Function
• Condition

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation	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.

Timeline

• Start date: 2022-08-18
• Primary completion: 2027-08-31
• Completion: 2027-08-31
• First posted: 2022-05-25
• Last updated: 2025-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study