Deep Brain Stimulation for Essential Tremor

(rT DBS Trial)

Overseen By Jeffrey Negrey, MA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: The Cleveland Clinic

Disqualifiers: Dementia, Epilepsy, Parkinson's, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 17 months

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for patients with severe tremors that haven't improved after treatments like Vim DBS or HIFU thalamotomy, or those who can't have these treatments due to specific types of tremor related to cerebellar outflow or multiple sclerosis (MS).

Inclusion Criteria

I am 21 years old or older.

Ability to give informed consent

A score of ≥24 on the Mini Mental State Examination

Exclusion Criteria

At risk for suicide defined by a score greater or equal to 3 on the Columbia Suicide Severity Rating Scale (C-SSRS)

I am not a candidate for deep brain stimulation surgery due to health risks.

A condition that, in the opinion of the clinical investigator, would significantly increase the risk or interfere with study compliance, safety, or outcome

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

DBS Implant Surgery

Participants undergo surgery for the implantation of the Medtronic Percept RC Deep Brain Stimulation System

1 week

1 visit (in-person)

Treatment

Participants receive electrical stimulation of the deep cerebellar nuclei for refractory tremor

17 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Deep Brain Stimulation

Trial Overview The study tests the safety and effectiveness of Deep Brain Stimulation (DBS) using Medtronic Percept RC System on deep cerebellar nuclei in people whose tremors are difficult to treat.

How Is the Trial Designed?

Group I: Refractory Tremor Experimental Treatment 1 Intervention

Medtronic Percept RC DBS System

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Medtronic

Industry Sponsor

Trials

627

Recruited

767,000+

Geoff Martha

Medtronic

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Richard Kuntz

Medtronic

Chief Medical Officer since 2023

MD, MSc

Raynor Cerebellum Project

Collaborator