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

Northwell Health40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Schizophrenia Cerebellar Function Condition

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Cerebellar function

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

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

Secondary Outcomes

Cognitive function

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