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

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Northwell Health

Status

Enrolling

Conditions

Cerebellar Function
Schizophrenia
Condition

Treatments

Device: Transcranial Magnetic Stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT05389787
22-0171

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Double Blind

60 participants in 2 patient groups

TMS
Experimental group
Treatment:
Device: Transcranial Magnetic Stimulation
Sham
Sham Comparator group
Treatment:
Device: Transcranial Magnetic Stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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