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NCT03984643 · ClinicalTrials.gov registry record · NA

Algorithms for Programming DBS Systems for ET

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

Recruiting
Registry status
NA
Development phase
25
Enrollment target
1
Study location

NCT03984643 is a NA study of Essential Tremor that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 25 participants, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03984643, a NA study of Essential Tremor, is actively recruiting participants, sponsored by University of Minnesota.

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

Study Summary

Deep brain stimulation (DBS) targeting the Vim thalamus (ventralis intermedius nucleus) is an FDA-approved neuromodulation therapy for treating postural and action tremor in individuals with essential tremor (ET). The success of this treatment, however, is highly dependent on the ability of clinicians to identify therapeutic stimulation settings through a laborious programming process. There is a strong and growing clinical need for new approaches to provide clinicians with more efficient guidance on how to titrate stimulation settings. This study will leverage subject-specific computational models that can predict neural activation of axonal pathways adjacent to the active electrode(s) and implicated in the therapeutic mechanisms of Vim-DBS to in turn guide clinicians with which stimulation settings are likely to be the most therapeutic on tremor.

Conditions Studied

Interventions

  • DEVICE Vim-Deep Brain Stimulation

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2019-10-01
Est. Completion 2031-12-31
Phase NA

Sponsor

University of Minnesota

966 total trials

What the Registry Record Tells You About NCT03984643

The ClinicalTrials.gov registry entry for NCT03984643 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 25 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 (94% lower). The listed sponsor is University of Minnesota, which has 966 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Essential Tremor appearing as the primary indexed condition, and to 1 intervention - of which Vim-Deep Brain Stimulation is the first listed.

NCT03984643 reports 1 study location spanning 1 distinct geographic area - top geographies include Minnesota.

Frequently Asked Questions

What is clinical trial NCT03984643 about?

NCT03984643 is a clinical study titled "Algorithms for Programming DBS Systems for ET". Deep brain stimulation (DBS) targeting the Vim thalamus (ventralis intermedius nucleus) is an FDA-approved neuromodulation therapy for treating postural and action tremor in individuals with essential tremor (ET). The success of this treatment, however, is highly dependent on the ability of clinicia...

What is the current status of trial NCT03984643?

This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2019-10-01. Estimated completion is 2031-12-31.

What conditions does trial NCT03984643 study?

This clinical trial studies the following conditions: Essential Tremor.

What interventions are being tested in trial NCT03984643?

The interventions under investigation include: Vim-Deep Brain Stimulation (DEVICE).

Who is sponsoring clinical trial NCT03984643?

This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03984643 being conducted?

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

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