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

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ClinicalTrials.gov Identifier: NCT01839396
Recruitment Status : Active, not recruiting
First Posted : April 24, 2013
Results First Posted : August 15, 2018
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Boston Scientific Corporation

Tracking Information
First Submitted Date  ICMJE April 22, 2013
First Posted Date  ICMJE April 24, 2013
Results First Submitted Date  ICMJE February 16, 2018
Results First Posted Date  ICMJE August 15, 2018
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE April 2013
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 22, 2013)
Improvement 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 mean number of waking hours per day with good symptom control and no troublesome dyskinesia, as measured on the PD Diary, with no increase in antiparkinsonian medications.
Change History Complete list of historical versions of study NCT01839396 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2018)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 22, 2013)
Secondary endpoints families [ Time Frame: From baseline to 12 weeks post-randomization ]
Secondary endpoints will be successively analyzed according to a parallel gatekeeping procedure with five endpoint families. Family 1: Difference between the active and control groups in the mean change in:
  • UPDRS-III score from baseline meds off to 12 weeks post-rand stim on/meds off;
  • UPDRS-III score from baseline meds on to 12 weeks post-rand stim on/meds on.
  • UDPRS-II score from baseline meds on to 12 weeks post-rand stim on/meds on.
Family 2: Difference between the two groups in the:
  • mean change in PDQ-39 score;
  • mean change in SE.
Family 3: Difference between the two groups in the:
  • mean CGI-C, as assessed by clinician;
  • mean CGI-C: Sub, as assessed by subject.
Family 4: Difference between the two groups in the treatment satisfaction score at 12 weeks post-rand. Family 5: Difference between the two groups in mean change in the SF-36v2 score.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: April 22, 2013)
Rates of occurance of specified adverse events [ Time Frame: Enrollment to 52 weeks post-randomization ]
Rates of occurrence of the following adverse device effects at 52 weeks post-randomization:
  • Cerebrovascular accident (CVA) and subdural hematomas;
  • Death;
  • Seizure;
  • Suicide or suicide attempt;
  • Motor/sensory symptoms;
  • Psychiatric symptoms other than suicide or suicide attempt.
 
Descriptive Information
Brief Title  ICMJE Deep Brain Stimulation (DBS) for the Treatment of Parkinson's Disease
Official Title  ICMJE Implantable Neurostimulator for the Treatment of Parkinson's Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Deep Brain Stimulation
  • 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.
    Intervention: Device: Deep Brain Stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 27, 2019)
313
Original Estimated Enrollment  ICMJE
 (submitted: April 22, 2013)
310
Estimated Study Completion Date  ICMJE August 2023
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01839396
Other Study ID Numbers  ICMJE G120075
CDM00049710/90876693 ( Other Identifier: BSC protocol number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boston Scientific Corporation
Study Sponsor  ICMJE Boston Scientific Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Boston Scientific Corporation
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP