Trial record 2 of 19 for:    intrepid

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

April 22, 2013
May 8, 2014
April 2013
July 2016   (final data collection date for primary outcome measure)
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.
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 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.
Complete list of historical versions of study NCT01839396 on ClinicalTrials.gov Archive Site
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.
Secondary endpoints families [ Time Frame: From baseline to 12 weeks post-randomization ] [ Designated as safety issue: No ]

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.

Not Provided
Rates of occurance of specified adverse events [ Time Frame: Enrollment to 52 weeks post-randomization ] [ Designated as safety issue: Yes ]

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

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
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.
  • 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.
    Intervention: Device: Deep Brain Stimulation
  • 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.
    Intervention: Device: Deep Brain Stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
310
July 2021
July 2016   (final data collection date for primary outcome measure)

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.
Both
22 Years to 75 Years
No
Contact: Alexander M Chernyak, BS 661-949-4855 alexander.chernyak@bsci.com
Contact: Diane Bowers 661-949-4175 Diane.Bowers@bsci.com
United States
 
NCT01839396
G120075, CDM00049710
Yes
Boston Scientific Corporation
Boston Scientific Corporation
Not Provided
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
Boston Scientific Corporation
May 2014

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