Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:

• 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

Locations
United States
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Jeffrey Negrey, MA
negreyj2@ccf.org
2163166896
Time Frame
Start Date: 2025-05-19
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 12
Treatments
Experimental: Refractory Tremor
Medtronic Percept RC DBS System
Sponsors
Leads: The Cleveland Clinic
Collaborators: Medtronic, Raynor Cerebellum Project

This content was sourced from clinicaltrials.gov

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