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One Pass thalamIc aNd subthalamIc stimulatiON

NCT02288468 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-07-21

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Vercise™ Deep Brain Stimulation System

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.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • University Hospital Freiburg

    lead OTHER

Principal Investigators

  • Volker Coenen, MD · University Hospital Freiburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2019-05-31
Completion
2020-11-18

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02288468 on ClinicalTrials.gov