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NCT Number: NCT05389787

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

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.

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Key information

Conditions

Schizophrenia Cerebellar Function Condition Disease Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zucker Hillside Hospital

New York, 11004, United States

Location status: Recruiting

Location contact

Hengyi Cao, PhD

CONTACT

[email protected]

7184705913

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Cerebellar function

    Time frame: end of 2nd week and 4th week

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

Secondary outcomes

  1. Cognitive function

    Time frame: end of 2nd week and 4th week

    Changes of scores for the Brief Assessment of Cognition in Schizophrenia (BACS) battery after TMS treatment compared with baseline

Other outcomes

  1. Cerebellum-cognition associations

    Time frame: end of 2nd week and 4th week

    Pearson Correlations between changes of cerebellar connectivity (as measured by fMRI) and changes of cognitive scores (as measured by BACS)

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 25, 2022
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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