Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the effectiveness of Deep Brain Stimulation as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication.
It is the first study in Parkinson patients outside the US with a Deep Brain Stimulation system using constant current instead of constant voltage and using a lead with an active electrode tip.
This study is designed as a prospective, observational, non-randomized, multi-centered study for 12 months in duration from implantation with the subjects being used as their own control. The primary outcome assessment will occur at three months: however, subjects will be followed for one year.
A comparison of measures within the same person from pre-treatment to post-treatment will be performed. Also, pre-treatment and post-treatment group means and standard deviations will be determined.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| UPDRS motor scores | Comparison of Parkinson's symptoms as demonstrated by the UPDRS motor scores in the medication 'Off' state at Baseline compared to the medication 'Off' with stimulation "On" 3 months after device implantation | [Time Frame: 3 months after device implantation]. |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction of therapy | Rate of subject and caregivers therapy satisfaction through 3, 6 month and 1 year | [through 3, 6 months and 1 year] |
| Economic burden of the disease | Rate on economic burden of the disease for caregiver determined from economic burden questionnaire at baseline and 1 year |
Not provided
Inclusion Criteria:
Subjects enrolled in this study must meet the following inclusion criteria:
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the following criteria:
Not provided
Not provided
Libra™/LibraXP™ DBS System Eligible subjects in this study will be screened to confirm that they meet the strict guidelines for advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication followed by surgery to implant the Libra™/LibraXP™ deep brain simulation system.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jan Vesper, Prof | Universitätsklinukum Dusseldorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Neurologique | Lyon | 69003 | France | |||
| CHU Laennec |
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| [at baseline and 1 year] |
| Rating on caregiver's burden determined from Zarit Caregivers Burden Interview (ZCBI) | [at baseline, 3 month and 1 year] |
| Assessment of the way of coping as determined from the Way of Coping Checklist (WCC) from caregiver | [baseline, 3,6 month and 1 year] |
| Nantes |
| 44799 |
| France |
| University Hospital Bonn | Bonn | Germany |
| University Hospital of Duesseldorf | Düsseldorf | Germany |
| University Hospital Regensburg | Regensburg | 93053 | Germany |
| Erciyes University Medicine School | Kayseri | Turkey (Türkiye) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |