RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-08-18
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05389787

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Male or female subjects 18 to 60 years of age
  2. 2. DSM-V diagnosis of schizophrenia spectrum disorders
  3. 3. Competent to provide informed consent
  1. 1. Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders
  2. 2. Lifetime diagnosis of ataxia or other cerebellar disorders
  3. 3. Lifetime diagnosis of mental retardation, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, or other neurodegenerative disorders
  4. 4. Any active general medical condition or CNS disease which can affect cognition or response to treatment
  5. 5. Substance dependence or abuse in the past six months
  6. 6. Seizure history
  7. 7. TMS within three months or ECT within six months
  8. 8. Pregnancy as indicated by self-report
  9. 9. MRI contraindications

Contacts and Locations

Study Locations (Sites)

Zucker Hillside Hospital
New York, New York, 11004
United States

Collaborators and Investigators

Sponsor: Northwell Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-18
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2022-08-18
Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Schizophrenia
  • Cerebellar Function
  • Condition