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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: Recruiting NA study of Essential Tremor, sponsored by University of Florida.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Tremor rating scale This 5-point scale rates tremor severity based on tremor amplitude, from 0 (no tremor) to 4 (severe tremor) in each part of the body, and includes assessments of specific abilities and functional disability.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-12-24 |
| Est. Completion | 2029-12-31 |
| Phase | NA |
What NCT04212780 shows while recruiting
NCT04212780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04212780's enrollment target sits among peer trials
10 42nd of 41 the lowest of 41 other Essential Tremor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Essential Tremor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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