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RECRUITING NA

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

NCT04212780 · View on ClinicalTrials.gov ↗

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

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

1,066 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04212780

The ClinicalTrials.gov registry entry for NCT04212780 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,066 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04212780 reports 1 study location spanning 1 distinct geographic area — top geographies include Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04212780?

This trial is sponsored by University of Florida, which has 1,066 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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