Brain Stimulation for Essential Tremor
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It focuses on brain stimulation for Essential Tremor, so it's best to ask the study team for guidance.
What data supports the effectiveness of the treatment for essential tremor?
Research shows that symmetric biphasic pulses can increase the therapeutic window (range of doses that are effective without causing side effects) in deep brain stimulation for essential tremor, potentially reducing side effects like ataxia (lack of muscle control). Shorter pulse widths may also help reduce side effects, although their long-term benefits need further study.12345
Is brain stimulation for essential tremor generally safe?
How is the treatment 'Active biphasic pulse stimulation' unique for essential tremor?
This treatment uses symmetric biphasic pulses, which can increase the therapeutic window (range of effective doses) and reduce side effects like ataxia (loss of control of body movements) compared to traditional methods. It offers a novel approach by modifying the pulse shape and width, potentially improving effectiveness and minimizing side effects.12478
What is the purpose of this trial?
This project aims to investigate novel ways to deliver brain stimulation to Essential Tremor (ET) patients by introducing software changes to their existing devices. The study team aims to investigate safety and efficacy of these new stimulation parameters in patients with ET.
Research Team
Joshua K Wong, MD
Principal Investigator
Univeristy of Florida
Eligibility Criteria
This trial is for people with Essential Tremor who already have a brain stimulation device implanted. They should be mentally sharp (with an MMSE score over 24) and have noticed their tremor control isn't as good as it was after surgery, even on two different check-ups.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive active biphasic pulse stimulation through their DBS devices with various settings tested, including Home Settings, VIN Biphasic, and Stimulator Off, with a 30-minute washout period between conditions.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of tremor severity and gait impairment.
Treatment Details
Interventions
- Active biphasic pulse stimulation---Home Settings
- Active biphasic pulse stimulation---Stimulator Off
- Active biphasic pulse stimulation---VIN Biphasic
Active biphasic pulse stimulation---Home Settings is already approved in European Union, United States for the following indications:
- Essential Tremor
- Essential Tremor
- Parkinson's Disease
- Dystonia
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
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