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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: Recruiting NA study of Essential Tremor, sponsored by University of Minnesota.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Quantify how therapeutic windows (i.e. stimulus amplitude threshold difference between postural and action tremor abolishment and side effect emergence) change over time with human Vim-DBS therapy. During routine clinical evaluation sessions, monopolar stimulation will be applied through each electrode to generate therapeutic window maps and quantify the degree to which stimulus amplitude thresholds for action and postural tremor abolishment and for generating side effects of stimulation (e.g. t
Conditions Studied
Interventions
- DEVICE Vim-Deep Brain Stimulation
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2019-10-01 |
| Est. Completion | 2031-12-31 |
| Phase | NA |
What NCT03984643 shows while recruiting
NCT03984643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 402-participant average among 41 other Essential Tremor trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Essential Tremor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03984643's enrollment target sits among peer trials
25 29th of 41 higher than 12 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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