Condition: Essential Tremor · Sponsor: University of Florida
This is a feasibility study based on physician-initiated Investigational Device Exemption (IDE) including intraoperative experiments and chronic testing of implanted dual thalamic DBS lead systems. This study will inform protocols for optimal use of implanted next-gen DBS systems for primarily tremor control in refractory essential tremor.If the approach appears to be successful, the pilot data generated will be used to base a future pivotal trial for FDA approval for enhanced tremor control and adaptive DBS (aDBS) functionality of DBS systems.
This description comes directly from the study's public registry record.
Cami Swartz · 352-733-2429 · cami.swartz@neurology.ufl.edu
Karim Oweiss, PhD · 352-294-1898 · koweiss@ufl.edu
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| University of Florida | Gainesville, Florida, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT04212780