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

NCT05389787 | Recruiting DMC FDA Device

• 1 other identifier: 22-0171
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Cerebellar function

  Changes of cerebellar connectivity after TMS treatment compared with baseline, as measured by functional magnetic resonance imaging (fMRI)

  end of 2nd week and 4th week

Secondary Outcomes (1)

• Cognitive function

  end of 2nd week and 4th week

Other Outcomes (1)

• Cerebellum-cognition associations

  end of 2nd week and 4th week

Study Arms (2)

TMS

EXPERIMENTAL

Device: Transcranial Magnetic Stimulation

Sham

SHAM COMPARATOR

Device: Transcranial Magnetic Stimulation

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.

Sham; TMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female subjects 18 to 60 years of age
• DSM-V diagnosis of schizophrenia spectrum disorders
• Competent to provide informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Zucker Hillside Hospital

New York, New York, 11004, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia; Disease

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: May 25, 2022
• Study Start: August 18, 2022
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)