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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
University of Florida
Study ID
NCT04212780
Status
Recruiting
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Conditions

  • Essential Tremor

Eligibility Criteria

Sex
ALL
Age
21 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Medtronic Summit Rechargable (RC)+S — DEVICE
    Dual channel closed-loop pulse generator with connection to both new DBS leads for deep stimulation of VIM vs VO
  • ipsilateral thalamic (VIM+VO) DBS — PROCEDURE
    Implantation of two new ipsilateral thalamic (VIM+VO) DBS
  • standard ET DBS — PROCEDURE
    Single Lead VIM
  • ipsilateral VO — PROCEDURE
    second lead in the ipsilateral VO

Study Details

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.

Key Dates

Start date
Dec 24, 2019
Status verified
Aug 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Active Comparator: Treatment Naive
    Participants receiving Long-term stimulation of the thalamus via dual leads for Essential Tremor
  • Active Comparator: Refractory Participants
    Patients with recurrent, debilitating intention tremor despite ongoing, optimized VIM DBS therapy

Primary Outcome Measure

Efficacy Assessment - Tremor [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611-

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By research site
University of Florida· Gainesville, FL

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