Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00552474
Recruitment Status : Completed
First Posted : November 2, 2007
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):
St. Jude Medical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Movement Disorders Device: Libra Deep Brain Stimulation System Not Applicable

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : October 2005
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: Group B
Implanted but no active stimulation
Device: Libra Deep Brain Stimulation System
Implanted system but no stimulation

Experimental: Group A
Active Stimulation
Device: Libra Deep Brain Stimulation System
Active DBS Therapy

Primary Outcome Measures :
  1. Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. Efficacy [ Time Frame: Yearly for 5 years ]
    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.

  2. Quality of life [ Time Frame: up to to 5 years ]
    Quality of Life measurements as measured by the Parkinson's Disease Questionnaire (PDQ 39)

  3. Activites of Daily Living [ Time Frame: up to 5 years ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00552474

United States, California
Loma Linda University School of Medicine
Loma Linda, California, United States, 92354
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Universtiy of Miami
Miami, Florida, United States, 33136
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
Oakwood Hospital
Dearborn, Michigan, United States, 48124
United States, New York
Mount Sinai School of Medicine
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14618
United States, Ohio
Mayfield Clinic
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Pennsylvania Hospital (UPHS)
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Neurology Specialists of Dallas
Dallas, Texas, United States, 75231
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Univerisity of Virginia
Charlottesville, Virginia, United States, 22903
United States, Wisconsin
Medical College of Wisconcin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
St. Jude Medical
Study Director: DeLea Peichel ANS/St Jude Medical

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: St. Jude Medical Identifier: NCT00552474     History of Changes
Other Study ID Numbers: C-04-01
First Posted: November 2, 2007    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

Keywords provided by St. Jude Medical:
Parkinson disease
Movement disorders
Deep Brain Stimulation
Electrical stimulation of the brain
Subthalamic nucleus

Additional relevant MeSH terms:
Parkinson Disease
Movement Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs