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NCT05897775 · ClinicalTrials.gov registry record · Phase 1
Coordinated Reset Deep Brain Stimulation for Essential Tremor
A Phase 1 study of Essential Tremor and Upper Extremity Essential Tremor, sponsored by University of Minnesota.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 1
- Study location
NCT05897775: Recruiting Phase 1 study of Essential Tremor and Upper Extremity Essential Tremor, sponsored by University of Minnesota.
NCT05897775 is a Phase 1 study of Essential Tremor and Upper Extremity Essential Tremor that is actively recruiting participants, run by University of Minnesota. The registered enrollment target is 23 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
NCT05897775, a Phase 1 study of Essential Tremor and Upper Extremity Essential Tremor, is actively recruiting participants, sponsored by University of Minnesota.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 1
- Study location
Study Summary
Deep brain stimulation (DBS) is a surgical procedure for the treatment of Essential Tremor (ET). A novel approach to current DBS approaches is called coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS that uses continuous high amplitude, high frequency stimulation. This study will evaluate the feasibility, safety and short-term efficacy of thalamic CR-DBS in upper extremity ET. The goal of this study is to evaluate the safety and short-term efficacy of thalamic CR- DBS in ET, including the acute (during CR-DBS) and carryover (following DBS cessation) effects, and compare these to those induced by clinically optimized T-DBS. To achieve our goal, a low-risk, two-phase clinical study will be conducted in patients with upper extremity (UE) ET. The first aim is to identify the spatial location and peak frequency of tremor related oscillatory activities in VIM (Phase I). The second aim is to compare the acute effects of thalamic CR-DBS to clinically optimized T-DBS (Phase II).
Primary Outcome
TETRAS is a rating scale introduced by the Tremor Research Group which has undergone extensive performance evaluations7. The TETRAS Activities of Daily Living Subscale (TETRAS-ADL) rates tremor's impact on activities of daily living, using 12 test items with each item scored from 0-4 (increasing with severity). The TETRAS-ADL total score range is 0-48. The TETRAS performance subscale (TETRAS-P) consists of 16 scored items designed to measure essential tremor of the head, face, voice, upper extr
Conditions Studied
Interventions
- DEVICE Deep brain stimulation
Study Locations (1)
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2023-09-11 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 1 |
What NCT05897775 shows while recruiting
NCT05897775 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 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 2 conditions, with Essential Tremor appearing as the primary indexed condition, and to 1 intervention - of which Deep brain stimulation is the first listed.
NCT05897775 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT05897775 about?
NCT05897775 is a clinical study titled "Coordinated Reset Deep Brain Stimulation for Essential Tremor". Deep brain stimulation (DBS) is a surgical procedure for the treatment of Essential Tremor (ET). A novel approach to current DBS approaches is called coordinated reset DBS (CR-DBS) which uses different patterns of stimulation at lower currents and can address the limitations of traditional DBS that ...
What is the current status of trial NCT05897775?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2023-09-11. Estimated completion is 2028-12-31.
What conditions does trial NCT05897775 study?
This clinical trial studies the following conditions: Essential Tremor, Upper Extremity Essential Tremor.
What interventions are being tested in trial NCT05897775?
The interventions under investigation include: Deep brain stimulation (DEVICE).
Who is sponsoring clinical trial NCT05897775?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05897775 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
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Where NCT05897775's enrollment target sits among peer trials
23 33rd of 41 higher than 9 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.
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