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RECRUITING
NCT04212780
NA

Dual Lead Thalamic Deep Brain Recording (DBR)-DBS Interface for Closed Loop Control of Severe Essential Tremor

Sponsor: University of Florida

View on ClinicalTrials.gov

Summary

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.

Official title: Dual Lead Thalamic DBR-DBS Interface for Closed Loop Control of Severe Essential Tremor

Key Details

Gender

All

Age Range

21 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2019-12-24

Completion Date

2029-12-31

Last Updated

2026-02-10

Healthy Volunteers

Yes

Interventions

DEVICE

Medtronic Summit Rechargable (RC)+S

Dual channel closed-loop pulse generator with connection to both new DBS leads for deep stimulation of VIM vs VO

PROCEDURE

ipsilateral thalamic (VIM+VO) DBS

Implantation of two new ipsilateral thalamic (VIM+VO) DBS

PROCEDURE

standard ET DBS

Single Lead VIM

PROCEDURE

ipsilateral VO

second lead in the ipsilateral VO

Locations (1)

University of Florida

Gainesville, Florida, United States