Closed-Loop Deep Brain Stimulation for Essential Tremor
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
Exclusion Criteria
Treatment Details
Interventions
- Closed-loop deep brain stimulation (Device)
- Deep brain stimulation (Device)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
Medtronic
Industry Sponsor
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