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.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, it mentions that your tremor should not be adequately controlled by medications for at least three months before the implant, suggesting you may need to continue your current treatment until the trial begins.
What data supports the effectiveness of the treatment Closed-loop Deep Brain Stimulation for Essential Tremor?
Research shows that closed-loop deep brain stimulation (DBS) can effectively reduce tremors in essential tremor patients by adjusting stimulation based on real-time feedback from sensors, which helps to minimize side effects and improve energy efficiency compared to traditional DBS. Studies have demonstrated that this approach can achieve similar tremor suppression as continuous DBS while using less energy, making it a promising treatment option.12345
Is closed-loop deep brain stimulation safe for humans?
Deep brain stimulation (DBS) has been used safely in humans for conditions like essential tremor and Parkinson's disease. Most reported side effects are mild and can be managed by adjusting the device settings. However, some complications like infections and device issues have been noted, which sometimes require additional surgery.16789
How is closed-loop deep brain stimulation treatment different from other treatments for essential tremor?
Closed-loop deep brain stimulation (DBS) is unique because it uses sensors to adjust the stimulation based on the patient's specific needs, providing feedback to deliver stimulation only when necessary. This approach can reduce side effects and extend the battery life of the device compared to traditional continuous (open-loop) DBS, which does not adapt to changes in the patient's condition.12101112
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgical Procedure
Participants undergo unilateral deep brain stimulation (DBS) implantation for essential tremor
Post-Surgery Follow-up
Participants are seen monthly post-surgery for 6 months to monitor the effects of DBS
Treatment Adjustment
Closed-loop deep brain stimulation may be offered and settings adjusted based on data assessment
Long-term Follow-up
Participants are monitored yearly if they continue active stimulation after the initial 24-month study period
Treatment Details
Interventions
- Closed-loop deep brain stimulation
- Deep brain stimulation
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