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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Boston Scientific Corporation
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT01839396
First received: April 22, 2013
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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 Intervention
Parkinson's Disease
Device: Deep Brain Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Implantable Neurostimulator for the Treatment of Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Boston Scientific Corporation:

Primary Outcome Measures:
  • Improvement in ON time as measured by Parkinson's disease diary [ Time Frame: From baseline to 12 weeks post-randomization ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Secondary Endpoints [ Time Frame: From baseline to 12 weeks post-randomization ] [ Designated as safety issue: No ]
    The UPDRS scale and quality of life assessments will be evaluated from baseline to 12 weeks post randomization.


Estimated Enrollment: 310
Study Start Date: April 2013
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Medium continuous dose of stimulation.
Subjects in this arm will receive a medium continuous dose of 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 be receiving a lower intermittent dose of 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.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   22 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01839396

Contacts
Contact: Alexander M Chernyak, BS 661-949-4855 alexander.chernyak@bsci.com
Contact: Diane Bowers 661-949-4175 Diane.Bowers@bsci.com

Locations
United States, California
Boston Scientific Clinical Research Information Toll Free Number Recruiting
Valencia, California, United States, 91355
Contact    855-213-9890    BSNClinicalTrials@bsci.com   
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Boston Scientific Corporation
ClinicalTrials.gov Identifier: NCT01839396     History of Changes
Other Study ID Numbers: G120075, CDM00049710
Study First Received: April 22, 2013
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 28, 2014