RecruitingNot ApplicableNCT05389787

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

Sponsor

Northwell Health

Enrollment

40 participants

Start Date

Aug 18, 2022

Study Type

INTERVENTIONAL

Conditions

Schizophrenia Cerebellar Function Condition

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether non-invasive magnetic brain stimulation aimed at the cerebellum (the part of the brain at the back of the head responsible for movement coordination and cognition) can improve memory, attention, and overall brain function in people with schizophrenia. **You may be eligible if...** - You are between 18 and 60 years old - You have been diagnosed with a schizophrenia spectrum disorder (such as schizophrenia or schizoaffective disorder) according to DSM-5 criteria - You are able to give informed consent **You may NOT be eligible if...** - You have another major psychiatric diagnosis in addition to schizophrenia - You have ever been diagnosed with a cerebellar disorder affecting balance or coordination - You have a history of epilepsy or seizures - You have metal implants in your head or body that make brain stimulation unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICETranscranial 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.