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

July 11, 2023 updated by: Boston Scientific Corporation

Implantable Neurostimulator for the Treatment of Parkinson's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

313

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Muhammad Ali Parkinson Research Center and Movement Disorders Clinic
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Sacramento, California, United States, 95825
        • Kaiser Permanente, Sacramento
      • San Francisco, California, United States, 94115
        • University of California, San Francisco
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Carepoint, PC d/b/a Blue Sky Neurology
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida Shands Hospital
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic, Jacksonville
      • Miami, Florida, United States, 33136
        • University of Miami, School of Medicine
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical Center
      • New York, New York, United States, 10016
        • NYU Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Health Sciences
    • Ohio
      • Cincinnati, Ohio, United States, 45129
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny Health Network
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Medium continuous dose of stimulation
Subjects in this arm will receive stimulation settings at a medium continuous dose of Deep Brain stimulation that may have been effective in previous DBS patients.
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.
Other Names:
  • Vercise™ Deep Brain Stimulation (DBS) system.
Sham Comparator: Low intermittent dose of stimulation
Subjects in this arm will receive stimulation settings at a lower intermittent dose of Deep Brain stimulation which is less likely to be effective.
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.
Other Names:
  • Vercise™ Deep Brain Stimulation (DBS) system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ON Time as Measured by Parkinson's Disease Diary
Time Frame: From baseline to 12 weeks post-randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoints
Time Frame: From baseline to 12 weeks post-randomization

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Principal Investigator: Jerrold Vitek, MD, PhD, University of Minnesota, Neurology Department
  • Principal Investigator: Philip Starr, MD, PhD, Universiry of California, San Francisco, Surgical Movement Disorders Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2013

Primary Completion (Actual)

December 27, 2016

Study Completion (Actual)

December 5, 2022

Study Registration Dates

First Submitted

April 22, 2013

First Submitted That Met QC Criteria

April 22, 2013

First Posted (Estimated)

April 24, 2013

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • G120075
  • CDM00049710/90876693 (Other Identifier: BSC protocol number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on Deep Brain Stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe