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

NCT04212780 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-02-10

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

    collaborator NIH

  • Medtronic

    collaborator INDUSTRY

  • University of Florida

    lead OTHER

Principal Investigators

  • Karim Oweiss, PhD · University of Florida

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-12-24
Primary Completion
2027-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04212780 on ClinicalTrials.gov