Summary

Eligibility
for people ages 22-75 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Jill Ostrem
Photo of Jill Ostrem
Jill Ostrem

Description

Summary

The purpose of this study is to evaluate the safety and effectiveness of Boston Scientific's Vercise Deep Brain Stimulation (DBS) system in the treatment of patients with with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication.

Official Title

Implantable Neurostimulator for the Treatment of Parkinson's Disease

Details

The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial. GUIDE XT may be used for planning of programming as needed.

Keywords

Parkinson's Disease Intrepid, Vercise, PD, DBS, Boston Scientific Parkinson Disease Deep Brain Stimulation Medium continuous dose of stimulation Low intermittent dose of stimulation

Eligibility

You can join if…

Open to people ages 22-75

  • Diagnosis of bilateral idiopathic PD (H&Y ≥ 2) with a duration of PD ≥ 5 years.
  • Persistent disabling Parkinson's disease symptoms or drug side effects (e.g., dyskinesias, motor fluctuations, or disabling "off" periods) despite optimal medical therapy.
  • Able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.

You CAN'T join if...

  • Any intracranial abnormality or medical condition that would contraindicate DBS surgery.
  • Have any significant psychiatric condition likely to compromise the subject's ability to comply with requirements of the study protocol
  • Any other active implanted devices including neurostimulators and /or drug delivery pumps
  • Any previous thalamotomy, pallidotomy or subjects who have undergone a DBS procedure.
  • Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints.
  • A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception.

Locations

  • University of California, San Francisco
    San Francisco California 94115 United States
  • Kaiser Permanente, Sacramento
    Sacramento California 95825 United States

Lead Scientist at UCSF

  • Jill Ostrem
    Professor, Neurology. Authored (or co-authored) 137 research publications.

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boston Scientific Corporation
ID
NCT01839396
Study Type
Interventional
Last Updated