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.
1 other identifier
interventional
136
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Oct 2005
Longer than P75 for not_applicable parkinson-disease
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 31, 2007
CompletedFirst Posted
Study publicly available on registry
November 2, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedFebruary 4, 2019
January 1, 2019
5 years
October 31, 2007
January 31, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias
90 days
Secondary Outcomes (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
1 year
Other Outcomes (3)
Efficacy
Yearly for 5 years
Quality of life
up to to 5 years
Activites of Daily Living
up to 5 years
Study Arms (2)
Group B
PLACEBO COMPARATORImplanted but no active stimulation
Group A
EXPERIMENTALActive Stimulation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Loma Linda University School of Medicine
Loma Linda, California, 92354, United States
University of Florida
Gainesville, Florida, 32610, United States
Universtiy of Miami
Miami, Florida, 33136, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Oakwood Hospital
Dearborn, Michigan, 48124, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia University Medical Center
New York, New York, 10032, United States
University of Rochester
Rochester, New York, 14618, United States
Mayfield Clinic
Cincinnati, Ohio, 45267, United States
Pennsylvania Hospital (UPHS)
Philadelphia, Pennsylvania, 19107, United States
Neurology Specialists of Dallas
Dallas, Texas, 75231, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Univerisity of Virginia
Charlottesville, Virginia, 22903, United States
Medical College of Wisconcin
Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 22239915DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
DeLea Peichel
ANS/St Jude Medical
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2007
First Posted
November 2, 2007
Study Start
October 1, 2005
Primary Completion
October 1, 2010
Study Completion
November 1, 2016
Last Updated
February 4, 2019
Record last verified: 2019-01