Movement Disorders, Parkinson Disease
Conditions
Keywords
Parkinson disease, Movement disorders, Deep Brain Stimulation, Libra, l-dopa, levodopa, neuromodulation, neurostimulation, Electrical stimulation of the brain, STN, Subthalamic nucleus
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.
Interventions
Active DBS Therapy
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase the duration of on time without dyskinesias or with non-bothersome dyskinesias | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Efficacy | 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. |
| Quality of life | up to to 5 years | Quality of Life measurements as measured by the Parkinson's Disease Questionnaire (PDQ 39) |
| Activites of Daily Living | 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 |
Countries
United States
Outcome results
None listed