Recruiting

Cerebellar TMS

Sponsor:

Northwell Health

Code:

NCT05389787

Conditions

Schizophrenia

Cerebellar Function

Condition

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Transcranial Magnetic Stimulation

Study Details

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

Study ID

NCT05389787

Start date

Aug 18, 2022

Status verified date

Sep, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TMS

sham comparator: Sham

Interventions

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.

Primary outcome measure

  • Cerebellar function [ Time Frame: end of 2nd week and 4th week ]

Central Contacts and Locations

Locations

Zucker Hillside Hospital

Recruiting

New York, New York, United States, 11004

Contacts

Hengyi Cao, PhD

7184705913hcao2@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Northwell Health on 2025-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.