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

NCT ID: NCT05389787

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-18

Study Completion Date

2027-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia Cerebellar Function Condition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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TMS

Group Type EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type 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

Group Type SHAM_COMPARATOR

Transcranial Magnetic Stimulation

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders
2. Lifetime diagnosis of ataxia or other cerebellar disorders
3. Lifetime diagnosis of mental retardation, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, or other neurodegenerative disorders
4. Any active general medical condition or CNS disease which can affect cognition or response to treatment
5. Substance dependence or abuse in the past six months
6. Seizure history
7. TMS within three months or ECT within six months
8. Pregnancy as indicated by self-report
9. MRI contraindications
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwell Health

OTHER

Sponsor Role lead

Responsible Party

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Hengyi Cao

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zucker Hillside Hospital

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Hengyi Cao, PhD

Role: primary

7184705913

Other Identifiers

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22-0171

Identifier Type: -

Identifier Source: org_study_id

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