Trial record 10 of 130 for:    Deep Brain Stimulation for Parkinson's Disease

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
  Purpose

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 Intervention
Parkinson Disease
Movement Disorders
Device: Libra Deep Brain Stimulation System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Advanced Neuromodulation Systems:

Primary Outcome Measures:
  • Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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


Enrollment: 136
Study Start Date: October 2005
Estimated Study Completion Date: June 2015
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Group B
Implanted but no active stimulation
Device: Libra Deep Brain Stimulation System
Implanted system but no stimulation
Other Name: Libra Deep Brain Stimulation System
Experimental: Group A
Active Stimulation
Device: Libra Deep Brain Stimulation System
Active DBS Therapy
Other Name: Libra Deep Brain Stimulation System

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552474

Locations
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
Columbia University Medical Center
New York, New York, United States, 10032
Mount Sinai School of Medicine
New York, New York, United States, 10029
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
Advanced Neuromodulation Systems
Investigators
Study Director: DeLea Peichel ANS/St Jude Medical
  More Information

Additional Information:
No publications provided

Responsible Party: Advanced Neuromodulation Systems
ClinicalTrials.gov Identifier: NCT00552474     History of Changes
Other Study ID Numbers: C-04-01
Study First Received: October 31, 2007
Last Updated: March 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Advanced Neuromodulation Systems:
Parkinson disease
Movement disorders
Deep Brain Stimulation
Electrical stimulation of the brain
Libra
l-dopa
levodopa
neuromodulation
neurostimulation
STN
Subthalamic nucleus

Additional relevant MeSH terms:
Movement Disorders
Parkinson Disease
Central Nervous System Diseases
Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on August 26, 2014