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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01839396
Recruitment Status : Active, not recruiting
First Posted : April 24, 2013
Results First Posted : August 15, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Device: Deep Brain Stimulation Not Applicable

Detailed Description:
The study is multi-center, prospective, double-blind, randomized (3:1) controlled trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 311 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implantable Neurostimulator for the Treatment of Parkinson's Disease
Actual Study Start Date : April 2013
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Vercise™ Deep Brain Stimulation (DBS) system.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839396


Locations
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United States, California
Los Angeles, California, United States, 90048
Boston Scientific Clinical Research Information Toll Free Number
Valencia, California, United States, 91355
Sponsors and Collaborators
Boston Scientific Corporation
Investigators
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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

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Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01839396     History of Changes
Other Study ID Numbers: G120075
CDM00049710/90876693 ( Other Identifier: BSC protocol number )
First Posted: April 24, 2013    Key Record Dates
Results First Posted: August 15, 2018
Last Update Posted: November 16, 2018
Last Verified: October 2018

Keywords provided by Boston Scientific Corporation:
Intrepid, Vercise, PD, DBS, Boston Scientific

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases