NCT05389787 Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
| NCT ID | NCT05389787 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-08-18 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2022-08-18 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT05389787 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05389787 currently recruiting?
Yes, NCT05389787 is actively recruiting participants. Visit ClinicalTrials.gov or contact Northwell Health to inquire about joining.
Where is the NCT05389787 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05389787 clinical trial?
NCT05389787 is sponsored by Northwell Health. The trial plans to enroll 40 participants.
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