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

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Deep Brain Stimulation
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Intrepid, Vercise, PD, DBS, Boston Scientific

Eligibility Criteria

22 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Muhammad Ali Parkinson Research Center and Movement Disorders Clinic
  • Cedars-Sinai Medical Center
  • Kaiser Permanente, Sacramento
  • University of California, San Francisco
  • Carepoint, PC d/b/a Blue Sky Neurology
  • University of Florida Shands Hospital
  • Mayo Clinic, Jacksonville
  • University of Miami, School of Medicine
  • Emory University
  • Northwestern Memorial Hospital
  • Rush University Medical Center
  • University of Kansas Hospital
  • University of Minnesota
  • Albany Medical Center
  • NYU Medical Center
  • Wake Forest Health Sciences
  • University of Cincinnati
  • Cleveland Clinic Foundation
  • Allegheny Health Network
  • Medical University of South Carolina
  • Vanderbilt University
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Medium continuous dose of stimulation

Low intermittent dose of stimulation

Arm Description

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.

Subjects in this arm will receive stimulation settings at a lower intermittent dose of Deep Brain stimulation which is less likely to be effective.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
April 22, 2013
Last Updated
July 11, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01839396
Brief Title
Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
Acronym
INTREPID
Official Title
Implantable Neurostimulator for the Treatment of Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 17, 2013 (Actual)
Primary Completion Date
December 27, 2016 (Actual)
Study Completion Date
December 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Intrepid, Vercise, PD, DBS, Boston Scientific

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
313 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medium continuous dose of stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Low intermittent dose of stimulation
Arm Type
Sham Comparator
Arm Description
Subjects in this arm will receive stimulation settings at a lower intermittent dose of Deep Brain stimulation which is less likely to be effective.
Intervention Type
Device
Intervention Name(s)
Deep Brain Stimulation
Other Intervention Name(s)
Vercise™ Deep Brain Stimulation (DBS) system.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in ON Time as Measured by Parkinson's Disease Diary
Description
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
Time Frame
From baseline to 12 weeks post-randomization
Secondary Outcome Measure Information:
Title
Secondary Endpoints
Description
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.
Time Frame
From baseline to 12 weeks post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerrold Vitek, MD, PhD
Organizational Affiliation
University of Minnesota, Neurology Department
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Philip Starr, MD, PhD
Organizational Affiliation
Universiry of California, San Francisco, Surgical Movement Disorders Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhammad Ali Parkinson Research Center and Movement Disorders Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Kaiser Permanente, Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Carepoint, PC d/b/a Blue Sky Neurology
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
University of Florida Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Mayo Clinic, Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami, School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
NYU Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Wake Forest Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45129
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Allegheny Health Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
32470421
Citation
Vitek JL, Jain R, Chen L, Troster AI, Schrock LE, House PA, Giroux ML, Hebb AO, Farris SM, Whiting DM, Leichliter TA, Ostrem JL, San Luciano M, Galifianakis N, Verhagen Metman L, Sani S, Karl JA, Siddiqui MS, Tatter SB, Ul Haq I, Machado AG, Gostkowski M, Tagliati M, Mamelak AN, Okun MS, Foote KD, Moguel-Cobos G, Ponce FA, Pahwa R, Nazzaro JM, Buetefisch CM, Gross RE, Luca CC, Jagid JR, Revuelta GJ, Takacs I, Pourfar MH, Mogilner AY, Duker AP, Mandybur GT, Rosenow JM, Cooper SE, Park MC, Khandhar SM, Sedrak M, Phibbs FT, Pilitsis JG, Uitti RJ, Starr PA. Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study. Lancet Neurol. 2020 Jun;19(6):491-501. doi: 10.1016/S1474-4422(20)30108-3. Epub 2020 May 26. Erratum In: Lancet Neurol. 2020 Sep;19(9):e8.
Results Reference
derived

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

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