NCT07049003 Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor

Trial Parameters

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Brief Summary

This objective of this study is to document the safety and feasibility of electrical stimulation of the deep cerebellar nuclei for refractory tremor using the Medtronic Percept RC Deep Brain Stimulation System. The population will consist of patients that have either failed a prior intervention (Vim DBS or HIFU thalamotomy) or determined to not be suitable candidates for Vim DBS or HIFU thalamotomy because they have a cerebellar outflow or MS-related tremor. Those patients with a previous intervention, must have a prior diagnosis of ET, cerebellar outflow tremor, or MS-related tremor. Subjects without a previous intervention must have a diagnosis of cerebellar outflow tremor or MS-related tremor.

Eligibility Criteria

Inclusion Criteria: * Age 21 years and older; * Ability to give informed consent; * Diagnosis of ET, cerebellar tremor, or MS-related tremor with a failed a prior intervention (VIM DBS or HIFU thalamotomy) or determined to not be suitable candidates for VIM DBS or HIFU thalamotomy because they have a cerebellar outflow or MS-related tremor. * Tremor history of at least three years; * Tremor that is refractory to medical management; * A score of ≥24 on the Mini Mental State Examination; * Inability to successfully perform ADLs without assistance or has lost interest in social, professional, or personal activities due to tremor Exclusion Criteria: * Any other neurological condition that could reduce the safety of study participation including central nervous system vasculitis and intracranial malignancy * A condition that, in the opinion of the clinical investigator, would significantly increase the risk or interfere with study compliance, safety, or outcome; * A diagnosis of dementia; *

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