Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor

NCT07049003 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: 25-182
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The incidence and nature of treatment-related adverse events

  The accumulation of adverse events across all subjects

  From DBS Implant Surgery through study completion, an average of 17 months

Secondary Outcomes (3)

• Fahn Tolosa Marin Tremor Rating Scale

  From DBS Implant Surgery through study completion, an average of 17 months

• DBS-evoked potentials

  From DBS Implant Surgery through study completion, an average of 17 months

• 4-8 HZ (theta) tremor related oscillations

  From DBS Implant Surgery through study completion, an average of 17 months

Study Arms (1)

Refractory Tremor

EXPERIMENTAL

Medtronic Percept RC DBS System

Device: Deep Brain Stimulation

Interventions

Deep Brain Stimulation DEVICE

Deep Brain Stimulation of the Deep Cerebellar Nuclei

Also known as: Medtronic Percept DBS System

Refractory Tremor

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Raynor Cerebellum Project: collaborator
• Medtronic: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

MeSH Terms

Conditions

Tremor; Essential Tremor

Interventions

Deep Brain Stimulation

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Jeffrey Negrey, MA

CONTACT

2163166896; negreyj2@ccf.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Institute Chief Neurological Institute

Model Details: All subjects will receive open label deep brain stimulation implantation of the deep cerebellar nuclei

Study Record Dates

• First Submitted: May 28, 2025
• First Posted: July 3, 2025
• Study Start: May 19, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)