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NCT04212780 · ClinicalTrials.gov registry record · NA

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

A NA study of Essential Tremor, sponsored by University of Florida.

Recruiting
Registry status
NA
Development phase
10
Enrollment target
1
Study location

NCT04212780 is a NA study of Essential Tremor that is actively recruiting participants, run by University of Florida. The registered enrollment target is 10 participants, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04212780, a NA study of Essential Tremor, is actively recruiting participants, sponsored by University of Florida.

RECRUITING
Registry status
NA
Development phase
10 participants
Enrollment target
1
Study location

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 Studied

Essential Tremor

Interventions

  • DEVICE Medtronic Summit Rechargable (RC)+S
  • PROCEDURE ipsilateral thalamic (VIM+VO) DBS
  • PROCEDURE standard ET DBS
  • PROCEDURE ipsilateral VO

Study Locations (1)

Florida

  • University of Florida - Gainesville

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2019-12-24
Est. Completion 2029-12-31
Phase NA

Sponsor

University of Florida

1,106 total trials

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What the Registry Record Tells You About NCT04212780

The ClinicalTrials.gov registry entry for NCT04212780 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (98% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Essential Tremor appearing as the primary indexed condition, and to 4 interventions - of which Medtronic Summit Rechargable (RC)+S is the first listed.

NCT04212780 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT04212780 about?

NCT04212780 is a clinical study titled "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 tremo...

What is the current status of trial NCT04212780?

This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2019-12-24. Estimated completion is 2029-12-31.

What conditions does trial NCT04212780 study?

This clinical trial studies the following conditions: Essential Tremor.

What interventions are being tested in trial NCT04212780?

The interventions under investigation include: Medtronic Summit Rechargable (RC)+S (DEVICE), ipsilateral thalamic (VIM+VO) DBS (PROCEDURE), standard ET DBS (PROCEDURE), ipsilateral VO (PROCEDURE).

Who is sponsoring clinical trial NCT04212780?

This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04212780 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.