Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor

NCT ID: NCT07049003

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-19
• Study Completion Date: 2028-12-31

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.

Conditions

Tremor; Essential Tremor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Refractory Tremor

Medtronic Percept RC DBS System

Group Type: EXPERIMENTAL

Deep Brain Stimulation

Intervention Type: DEVICE

Deep Brain Stimulation of the Deep Cerebellar Nuclei

Interventions

Deep Brain Stimulation

Deep Brain Stimulation of the Deep Cerebellar Nuclei

Intervention Type: DEVICE

Other Intervention Names

Medtronic Percept DBS System

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;
• Tremors due to other neurological conditions such as Parkinson's disease, dystonia, or other conditions not consistent with ET, cerebellar outflow tremor, or MS-related tremor.
• Diagnosis of epilepsy;
• Major active and untreated psychiatric illness that may interfere with study, such as psychotic disorders or severe personality disorders;
• Untreated or inadequately treated depression defined by a score of 20 or greater on the Beck Depression Inventory-II at the time of enrollment;
• At risk for suicide defined by a score greater or equal to 3 on the Columbia Suicide Severity Rating Scale (C-SSRS);
• Pregnancy;
• Unable to communicate with investigators or staff;
• Surgical contraindications to DN DBS;
• Contraindication to magnetic resonance (MRI) imaging, e.g., weight incompatible with scanner, implanted metallic devices or electrical devices (pacemaker, defibrillator, spinal cord stimulator, prior DBS) or intolerance to MRI contrast agent;
• Enrolled in another device, biologic or pharmaceutical study within 30 days of consent in the current study, (i.e., patient cannot be enrolled if participation in another study was not completed at least 30 days prior to consent.);
• Evidence of behavior(s) consistent with alcohol or substance abuse/dependence as defined by the criteria outlined in the DSM-V within the preceding six months;
• Injection of botulinum toxins into the arm, neck or face within six months prior to baseline;

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Raynor Cerebellum Project

UNKNOWN

Sponsor Role: collaborator

Medtronic

INDUSTRY

Sponsor Role: collaborator

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Andre Machado

Institute Chief Neurological Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jeffrey Negrey, MA

Role: CONTACT

negreyj2@ccf.org

2163166896

Facility Contacts

Jeffrey Negrey, MA

Role: primary

negreyj2@ccf.org

216-316-6896

Other Identifiers

25-182

Identifier Type: -

Identifier Source: org_study_id