Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease
Primary Purpose
Parkinson Disease, Movement Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Libra Deep Brain Stimulation System
Libra Deep Brain Stimulation System
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson disease, Movement disorders, Deep Brain Stimulation, Libra, l-dopa, levodopa, neuromodulation, neurostimulation, Electrical stimulation of the brain, STN, Subthalamic nucleus
Eligibility 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
Sites / Locations
- Loma Linda University School of Medicine
- University of Florida
- Universtiy of Miami
- Rush University Medical Center
- Lahey Clinic
- Oakwood Hospital
- Mount Sinai School of Medicine
- Columbia University Medical Center
- University of Rochester
- Mayfield Clinic
- Pennsylvania Hospital (UPHS)
- Neurology Specialists of Dallas
- Baylor College of Medicine
- Univerisity of Virginia
- Medical College of Wisconcin
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Group B
Group A
Arm Description
Implanted but no active stimulation
Active Stimulation
Outcomes
Primary Outcome Measures
Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias
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
Full Information
NCT ID
NCT00552474
First Posted
October 31, 2007
Last Updated
January 31, 2019
Sponsor
Abbott Medical Devices
1. Study Identification
Unique Protocol Identification Number
NCT00552474
Brief Title
Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease
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 Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
November 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Movement Disorders
Keywords
Parkinson disease, Movement disorders, Deep Brain Stimulation, Libra, l-dopa, levodopa, neuromodulation, neurostimulation, Electrical stimulation of the brain, STN, Subthalamic nucleus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
136 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
Implanted but no active stimulation
Arm Title
Group A
Arm Type
Experimental
Arm Description
Active Stimulation
Intervention Type
Device
Intervention Name(s)
Libra Deep Brain Stimulation System
Intervention Description
Active DBS Therapy
Intervention Type
Device
Intervention Name(s)
Libra Deep Brain Stimulation System
Intervention Description
Implanted system but no stimulation
Primary Outcome Measure Information:
Title
Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias
Time Frame
90 days
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
Efficacy
Description
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.
Time Frame
Yearly for 5 years
Title
Quality of life
Description
Quality of Life measurements as measured by the Parkinson's Disease Questionnaire (PDQ 39)
Time Frame
up to to 5 years
Title
Activites of Daily Living
Description
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
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DeLea Peichel
Organizational Affiliation
ANS/St Jude Medical
Official's Role
Study Director
Facility Information:
Facility Name
Loma Linda University School of Medicine
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Universtiy of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Lahey Clinic
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Oakwood Hospital
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Mayfield Clinic
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Pennsylvania Hospital (UPHS)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Neurology Specialists of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Univerisity of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Medical College of Wisconcin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22239915
Citation
Okun MS, Gallo BV, Mandybur G, Jagid J, Foote KD, Revilla FJ, Alterman R, Jankovic J, Simpson R, Junn F, Verhagen L, Arle JE, Ford B, Goodman RR, Stewart RM, Horn S, Baltuch GH, Kopell BH, Marshall F, Peichel D, Pahwa R, Lyons KE, Troster AI, Vitek JL, Tagliati M; SJM DBS Study Group. Subthalamic deep brain stimulation with a constant-current device in Parkinson's disease: an open-label randomised controlled trial. Lancet Neurol. 2012 Feb;11(2):140-9. doi: 10.1016/S1474-4422(11)70308-8. Epub 2012 Jan 11. Erratum In: Lancet Neurol. 2012 Mar;11(3):208.
Results Reference
derived
Links:
URL
http://www.ans-medical.com
Description
ANS specific website
Learn more about this trial
Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease
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