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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 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.

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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).

Conditions Studied

Essential Tremor Upper Extremity Essential Tremor

Interventions

  • DEVICE Deep brain stimulation

Study Locations (1)

Minnesota

  • University of Minnesota - Minneapolis

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2023-09-11
Est. Completion 2028-12-31
Phase Phase 1

Sponsor

University of Minnesota

966 total trials

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What the Registry Record Tells You About NCT05897775

The ClinicalTrials.gov registry entry for NCT05897775 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 23 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 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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.