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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05389787
• Other study ID #: 22-0171
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: September 2023
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebellar Function
• Condition
• Schizophrenia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Zucker Hillside Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebellum-cognition associations	Pearson Correlations between changes of cerebellar connectivity (as measured by fMRI) and changes of cognitive scores (as measured by BACS)	end of 2nd week and 4th week
Primary	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	Cognitive function	Changes of scores for the Brief Assessment of Cognition in Schizophrenia (BACS) battery after TMS treatment compared with baseline	end of 2nd week and 4th week