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

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Transcranial Magnetic Stimulation — DEVICE
    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.

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)

FacilityCityStateZIPSite coordinators
Zucker Hillside HospitalNew YorkNew York11004
Hengyi Cao, PhD
7184705913

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