Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Advanced Neuromodulation Systems
ClinicalTrials.gov Identifier:
NCT00552474
First received: October 31, 2007
Last updated: March 12, 2014
Last verified: March 2014

October 31, 2007
March 12, 2014
October 2005
October 2010   (final data collection date for primary outcome measure)
Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias [ Time Frame: 90 days ]
Complete list of historical versions of study NCT00552474 on ClinicalTrials.gov Archive Site
Changes in the following over time: Incidence of AEs; UPDRS motor scores; Activities of Daily Living; Quality of Life, Quality Sleep Index, Hoehn and Yahr Staging, Global Outcome evaluation and Patient Satisfaction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Changes in the following over time: Incidence of AEs; UPDRS motor scores; Activities of Daily Living; Quality of Life, Quality Sleep Index, Hoehn and Yahr Staging, Global Outcome evaluation and Patient Satisfaction [ Time Frame: 1 year ]
  • Efficacy [ Time Frame: Yearly for 5 years ] [ Designated as safety issue: No ]
    Reduction in Parkinson's symptoms as demonstrated by the total UPDRS scores and each individual component of the UPDRS in the medication on and off state with stimulation on at 2 years, 3 years, 4 years, and 5 years.
  • Quality of life [ Time Frame: up to to 5 years ] [ Designated as safety issue: No ]
    Quality of Life measurements as measured by the Parkinson's Disease Questionnaire (PDQ 39)
  • Activites of Daily Living [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    Activities of Daily Living measurement at 2 years, 3 years, 4 years, and 5 years as determined from the Unified Parkinson's Disease Rating Scale (UPDRS) in the medication on and stimulation on state
Not Provided
 
Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease
A Clinical Evaluation of Bilateral Stimulation of the Subthalamic Nucleus (STN) Using the ANS Totally Implantable Deep Brain Stimulation System as an Adjunctive Treatment for Reducing Some of the Symptoms of Advanced, Levodopa-responsive Parkinson's Disease That Are Not Adequately Controlled With Medication.

The purpose of this study is to evaluate the safety and efficacy of bilateral stimulation of the subthalamic nucleus (STN) of the brain when using the ANS Totally Implantable Deep Brain Stimulation System as an adjunctive treatment for reducing some of the symptoms of Parkinson's Disease that are not adequately controlled with medication.

This is a prospective, controlled, multi-centered, 12 months post-implantation study. A maximum of 15 sites will enroll a total of 136 patients.

All study participants will have the study device surgically implanted. After implant surgery, study participants will return to the clinic for evaluation 30 days after surgery, three months after surgery, six months after surgery and twelve months after surgery. At the baseline, three, six and twelve month visits the patient's Parkinson's symptoms and ability to perform daily activities will be evaluated using a number of accepted assessment tools including a Dyskinesia diary, evaluation of PD symptoms, quality of life scoring and patient extension study to monitor the safety and efficacy of the ANS Libra/Libra Deep Brain Stimulation System.

After the 1 year study, patients may enter another protocol (C-06-04) to continue to monitor the safety and efficacy of the Libra Deep Brain Stimulation System. Patients may be followed for an additional 4 years.

If necessary, patients may continue to have access to the investigational device under protocol (C-13-02) which allows for compassionate use access to it.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Parkinson Disease
  • Movement Disorders
  • Device: Libra Deep Brain Stimulation System
    Active DBS Therapy
    Other Name: Libra Deep Brain Stimulation System
  • Device: Libra Deep Brain Stimulation System
    Implanted system but no stimulation
    Other Name: Libra Deep Brain Stimulation System
  • Placebo Comparator: Group B
    Implanted but no active stimulation
    Intervention: Device: Libra Deep Brain Stimulation System
  • Experimental: Group A
    Active Stimulation
    Intervention: Device: Libra Deep Brain Stimulation System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
136
June 2015
October 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Person is 18 to 80 years of age
  • Person has been diagnosed with Parkinson's disease for at lease five (5) years
  • Person experiences at least six (6) hours or more daily "off-time" or moderate to severe dyskinesias during waking hours
  • Person has a history of improvement of Parkinson's symptoms with l-dopa (levodopa) therapy
  • Person must be willing to maintain a constant dose of anti-Parkinson's disease medication for at least one month prior to study enrollment
  • Person must be available for appropriate follow-up times for the length of the study

Exclusion Criteria:

  • Person has any major illness or medical condition that would interfere with participation in the study
  • Person currently suffers from untreated, major depression
  • Person has an electrical or electromagnetic implant (e.g. cochlear prosthesis or pacemaker)
  • Person has had a prior surgery for the treatment of PD symptoms, including previous DBS surgery
  • Person has dementia
  • Person has a history of seizures
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00552474
C-04-01
Yes
Advanced Neuromodulation Systems
Advanced Neuromodulation Systems
Not Provided
Study Director: DeLea Peichel ANS/St Jude Medical
Advanced Neuromodulation Systems
March 2014

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