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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group B | Placebo Comparator | Implanted but no active stimulation |
|
| Group A | Experimental | Active Stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Libra Deep Brain Stimulation System | Device | Active DBS Therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias | 90 days |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | 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. | Yearly for 5 years |
| Quality of life |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| DeLea Peichel | ANS/St Jude Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University School of Medicine | Loma Linda | California | 92354 | United States | ||
| University of Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22239915 | Derived | 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. |
| Label | URL |
|---|---|
| ANS specific website | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 8, 2022 | |
| Reset | Dec 6, 2022 | |
| Release | Dec 8, 2023 |
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| Libra Deep Brain Stimulation System |
| Device |
Implanted system but no stimulation |
|
Quality of Life measurements as measured by the Parkinson's Disease Questionnaire (PDQ 39) |
| up to to 5 years |
| Activites of Daily Living | 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 | up to 5 years |
| 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 |
| Reset | Dec 27, 2023 |
| Release | Jan 22, 2024 |
| Reset | Feb 13, 2024 |
| Release | Sep 5, 2024 |
| Reset | Sep 30, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 8, 2022 | Dec 6, 2022 | |||
| Dec 8, 2023 | Dec 27, 2023 | |||
| Jan 22, 2024 | Feb 13, 2024 | |||
| Sep 5, 2024 | Sep 30, 2024 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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