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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01839396
Other study ID # G120075
Secondary ID CDM00049710/9087
Status Completed
Phase N/A
First received
Last updated
Start date May 17, 2013
Est. completion date December 5, 2022

Study information

Verified date July 2023
Source Boston Scientific Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 313
Est. completion date December 5, 2022
Est. primary completion date December 27, 2016
Accepts healthy volunteers No
Gender All
Age group 22 Years to 75 Years
Eligibility Key Inclusion Criteria: - 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. Key Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Deep Brain Stimulation
The Verciseā„¢ DBS system will be implanted in subjects in both study arms. Stimulation parameters will vary depending on the study arm assignment. All subjects will receive therapeutic settings at the end of the blinded period.

Locations

Country Name City State
United States Albany Medical Center Albany New York
United States Emory University Atlanta Georgia
United States Medical University of South Carolina Charleston South Carolina
United States Northwestern Memorial Hospital Chicago Illinois
United States Rush University Medical Center Chicago Illinois
United States University of Cincinnati Cincinnati Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Carepoint, PC d/b/a Blue Sky Neurology Englewood Colorado
United States University of Florida Shands Hospital Gainesville Florida
United States Mayo Clinic, Jacksonville Jacksonville Florida
United States University of Kansas Hospital Kansas City Kansas
United States Cedars-Sinai Medical Center Los Angeles California
United States University of Miami, School of Medicine Miami Florida
United States University of Minnesota Minneapolis Minnesota
United States Vanderbilt University Nashville Tennessee
United States NYU Medical Center New York New York
United States Muhammad Ali Parkinson Research Center and Movement Disorders Clinic Phoenix Arizona
United States Allegheny Health Network Pittsburgh Pennsylvania
United States Kaiser Permanente, Sacramento Sacramento California
United States University of Utah Salt Lake City Utah
United States University of California, San Francisco San Francisco California
United States Wake Forest Health Sciences Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in ON Time as Measured by Parkinson's Disease Diary Difference in the mean change from baseline to 12 weeks post-randomization between the active and control groups in the ON time as measured by Parkinson's diary. Positive indicates improvement From baseline to 12 weeks post-randomization
Secondary Secondary Endpoints Change in Unified Parkinson's Disease Rating Scale (UDPRS) Part III (stim on/meds off) from baseline to 12 weeks post randomization.
Range of UPDRS III is 0 - 108 with greater scores indicating worse disease state.
From baseline to 12 weeks post-randomization
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