Clinical trial NCT00552474: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2007-11-02
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias
timeFrame: 90 days
Secondary outcomes:
measure: 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
timeFrame: 1 year
Other outcomes:
measure: Efficacy
timeFrame: Yearly for 5 years
measure: Quality of life
timeFrame: up to to 5 years
measure: Activites of Daily Living
timeFrame: up to 5 years
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University School of Medicine
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: Universtiy of Miami
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Burlington
country: United States
facility: Lahey Clinic
state: Massachusetts
city: Dearborn
country: United States
facility: Oakwood Hospital
state: Michigan
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cincinnati
country: United States
facility: Mayfield Clinic
state: Ohio
city: Philadelphia
country: United States
facility: Pennsylvania Hospital (UPHS)
state: Pennsylvania
city: Dallas
country: United States
facility: Neurology Specialists of Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Charlottesville
country: United States
facility: Univerisity of Virginia
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconcin
state: Wisconsin
Study officials:
affiliation: ANS/St Jude Medical
name: DeLea Peichel
role: STUDY_DIRECTOR
References:
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.