Closed-Loop Deep Brain Stimulation for Essential Tremor

Overseen by Aysegul Gunduz, Ph.D

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Florida

No Placebo Group

Trial Summary

What is the purpose of this trial?

Essential tremor is an incurable, degenerative brain disorder that results in increasingly debilitating tremor, and afflicts an estimated 7 million people in the US. In one study, 25% of essential tremor patients were forced to change jobs or take early retirement because of tremor. Essential tremor is directly linked to progressive functional impairment, social embarrassment, and even depression. The tremor associated with essential tremor is typically slow, involves the hands (and sometimes the head and voice), worsens with intentional movements, and is insidiously progressive over many years. Deep brain stimulation has emerged as a highly effective treatment for intractable, debilitating essential tremor. However, since the intention tremor of essential tremor is typically intermittent, and commonly absent at rest, the currently available continuous deep brain stimulation may be delivering unnecessary current to the brain that increases undesirable side effects such as slurred speech and walking difficulty, and hastens the depletion of device batteries, necessitating more frequent surgical procedures to replace spent pulse generators. The overall objective of this early feasibility study is to provide preliminary data on the safety and efficacy of "closed-loop" deep brain stimulation for intention tremor using novel deep brain stimulation devices capable of continuously sensing brain activity and delivering therapeutic stimulation only when necessary to suppress tremor.

Research Team

Aysegul Gunduz, Ph.D

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for adults over 21 with severe essential tremor in the arms that hasn't improved after trying at least two medications, including propranolol or primidone. Participants must have had this condition for at least three years and be able to attend all study follow-ups. Pregnant individuals, those with substance abuse issues, major health problems, previous brain surgeries, Parkinsonian features, recent seizures or psychosis are not eligible.

Inclusion Criteria

You have experienced difficulty with speaking, eating, drinking, personal hygiene, dressing, writing, working, or social activities, as measured by a specific scoring system.

You provide informed consent.

You are available for appropriate follow-up times for the length of the study.

Exclusion Criteria

In addition, patients who are pregnant or plan to become pregnant will be excluded from this study.

I may have symptoms like slow movement, stiffness, or balance problems.

You have a history of alcohol or drug abuse as outlined in the DSM-V.

Treatment Details

Interventions

• Closed-loop deep brain stimulation (Device)
• Deep brain stimulation (Device)

Trial Overview The study tests a new 'closed-loop' deep brain stimulation device designed to treat arm tremors by delivering electrical impulses only when needed. This could reduce side effects compared to traditional continuous stimulation and extend battery life of the device.

Participant Groups

Group I: Deep brain stimulation Experimental Treatment 2 Interventions

All participants will undergo unilateral deep brain stimulation (DBS) implantation for essential tremor. Medtronic Summit RC+S devices will be used because these are capable of recording brain signals, as well as delivering DBS. Participants will receive continuous (open-loop) and closed-loop deep brain stimulation interventions, which will be compared for efficacy.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

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

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+