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

Not Applicable

Recruiting

• Conditions: Schizophrenia; Cerebellar Function; Condition
• Interventions: Device: Transcranial Magnetic Stimulation

• Registration Number: NCT05389787
• Lead Sponsor: Northwell Health

Brief Summary

This is a single-site, sham-controlled, randomized trial in a total of 60 subjects between ages 18 and 40 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

Not available

Study Timeline

• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-20
• Study First Posted: 2022-05-25
• Study Start: 2022-08-18
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-13
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female subjects 18 to 40 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

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
TMS	Transcranial Magnetic Stimulation	-
Sham	Transcranial Magnetic Stimulation	-

Primary Outcome Measures

Name	Time	Method
Cerebellar function	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 Outcome Measures

Name	Time	Method
Cognitive function	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

Trial Locations

Locations (1)

Zucker Hillside Hospital; 🇺🇸 New York, New York, United States