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Dual Lead Thalamic Deep Brain Recording (DBR)-DBS Interface for Closed Loop Control of Severe Essential Tremor
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.
Details
| Lead sponsor | University of Florida |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 10 |
| Start date | Tue Dec 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Dec 31 2029 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Essential Tremor
Interventions
- Medtronic Summit Rechargable (RC)+S
- ipsilateral thalamic (VIM+VO) DBS
- standard ET DBS
- ipsilateral VO
Countries
United States