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Implantable Neurostimulator for the Treatment of Parkinson’s Disease Protocol (INTREPID Study)
Overall Recruitment Status: Active, enrollment completed
 
Official Title
Implantable Neurostimulator for the Treatment of Parkinson's Disease
 
Region Sponsors
California - Northern
Boston Scientific Corporation
 
Acronym KP IRB No.
INTREPID CN-13-1669-B
 
Study Type Phase
Clinical Trial n/a
 
Study Population Description
Individuals with Parkinson's Disease
 
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.
 
Detailed Description
This study will evaluate the safety and effectiveness of the Boston Scientific implantable deep brain stimulation (DBS) Vercise™ system for bilateral stimulation of the subthalamic nucleus (STN) as an adjunctive therapy for improving the number of waking hours per day with good symptom control and no troublesome dyskinesia (ON time) in adults with advanced, levodopa-responsive bilateral Parkinson's disease (PD) which is not adequately controlled with medication. The study will also evaluate the effectiveness of STN-DBS with the Vercise™ system on secondary health outcomes including general quality of life measures, dyskinesia severity, levodopa equivalent medication use, and the severity of PD symptoms in subjects with advanced, levodopa-responsive Parkinson’s disease.
 
Gender Age Limit
Male & Female 22 - 75 years
 
Inclusion Criteria
  • Diagnosis of bilateral idiopathic PD (H&Y greater than or equal to 2) with a duration of PD greater than or equal to 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
 
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

 
Keywords and/or Specific Medical Conditions
  • DBS
  • Vercise
  • Parkinson Disease
  • Intrepid
  • PD
  • Neurology (Neurological Disorders)
 
KP Clinical Facility
  • Redwood City Medical Center
  • Sacramento Medical Center
 
Clinical Area
  • Neurology (Neurological Disorders)


Principal Investigator:
Suketu M Khandhar , MD
Contact Information:
- Diana M Bruce
-diana.m.bruce@kp.org
-Sacramento Medical Center


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