Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease

Parkinson's Disease Clinical Trial

— INTREPID  

Official title:

Implantable Neurostimulator for the Treatment of Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01839396
• Other study ID #: G120075
• Secondary ID: CDM00049710/9087
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Deep Brain Stimulation
The Vercise™ 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