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Bilateral Pallidal Stimulation in Patients With Advanced Parkinson's Disease-LATESTIM

NCT02823158 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-10-22

No results posted yet for this study

Summary

Deep brain stimulation (DBS) is an established treatment for advanced complicated Parkinson's disease (PD). Several controlled randomized studies have given proof of an advantage for operated patients as compared to medically treated patients in terms of motor outcome, activities of daily living and health status. However these studies have addressed mostly stimulation of the subthalamic nucleus (STN). GPi stimulation has not been compared to best medical treatment (BMT) in a prospective randomized controlled trial in patients with complicated PD who are not good candidates for STN stimulation. The investigators aim assessing GPi-DBS in patients with PD who have contraindications for STN-DBS.

Conditions

Interventions

PROCEDURE

Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT)

Patients in the GPi group will be implanted with DBS-electrodes within 6 weeks after randomisation. The stimulation parameters and the medical treatment are adjusted for optimal control of motor and non-motor signs and symptoms according to published guidelines using a specified algorithm. The stimulation parameters are recorded at the beginning and at the end of each post-surgical assessment. Best medical treatment is applied in combination with GPi-DBS.

PROCEDURE

Best medical treatment

Patients will receive optimized medical treatment according to published evidence based guidelines.

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Michael Schüpbach, PD Dr. med · Inselspital University Hospital Bern

  • Ines Debove, Dr. med · Inselspital University Hospital Bern

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • Switzerland

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 NCT02823158 on ClinicalTrials.gov