CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Vercise™ Deep Brain Stimulation Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02288468
NCT02288468N/ACompleted
CompareCT.gov

One Pass thalamIc aNd subthalamIc stimulatiON

University Hospital Freiburg·interventional·Posted Nov 11, 2014·Updated Jul 21, 2021

In Brief

A clinical study evaluating Vercise™ Deep Brain Stimulation System for Parkinson's Disease. Completed, enrolled 12 participants across 1 site.

Detailed Summary

Main part of the study: Randomised, active controlled, double blinded (patient and observer blinded), monocentric trial with three treatments, three periods and six treatment sequences allocated according to a Williams design Open Label Extension: After study treatment as described above, patients will be treated unblinded in their preferred stimulation mode until 36 months after implantation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson's Disease
CountriesGermany
CollaboratorsBoston Scientific Corporation

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 11, 2014
Enrollment StartJul 1, 2015
Primary CompletionMay 1, 2019
Study CompletionNov 18, 2020
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 11.6 years ago

Interventions

Vercise™ Deep Brain Stimulation Systemdevice

The Vercise™ DBS System includes a Stimulator with DBS Leads for unilateral or bilateral stimulation. There are also DBS Extensions that allow the DBS Leads mounted in the skull to be extended to reach the Stimulator implanted near the clavicle. The rechargeable Vercise DBS System utilizes current steering across eight contacts per DBS Lead to provide precise positioning of stimulation. The Stimulator is controlled by a handheld Remote Control, and can be interfaced with a Clinician's Programmer using the Bionic Navigator™ Software. Periodically, the Stimulator battery must be replenished with an RF (radiofrequency) charging device provided in the Patient DBS Charging Kit.