Post Market (Libra/LibraXP System) Deep Brain Stimulation (DBS) Parkinson's Disease Study
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Purpose
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 will be the first study in Parkinson's 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.
| Condition |
|---|
|
Parkinson's Disease |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Post Market Clinical Evaluation 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 |
- UPDRS motor scores [ Time Frame: [Time Frame: 3 months after device implantation]. ] [ Designated as safety issue: No ]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
- Satisfaction of therapy [ Time Frame: [through 3, 6 months and 1 year] ] [ Designated as safety issue: No ]Rate of subject and caregivers therapy satisfaction through 3, 6 month and 1 year
- Economic burden of the disease [ Time Frame: [at baseline and 1 year] ] [ Designated as safety issue: No ]Rate on economic burden of the disease for caregiver determined from economic burden questionnaire at baseline and 1 year
- Rating on caregiver's burden determined from Zarit Caregivers Burden Interview (ZCBI) [ Time Frame: [at baseline, 3 month and 1 year] ] [ Designated as safety issue: No ]
- Assessment of the way of coping as determined from the Way of Coping Checklist (WCC) from caregiver [ Time Frame: [baseline, 3,6 month and 1 year] ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2011 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Subjects enrolled in this study must meet the following inclusion criteria:
- Subject has signed an informed consent.
- Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease.
- Subject is a candidate for surgery.
- Subject is 18 to 80 years of age.
- Subject has a history of improvement of Parkinson's symptoms as a direct result of administering l-dopa to the subject with at least a 25% improvement in Unified Parkinson's Disease Rating Scale (UPDRS) motor score or subject has been diagnosed with tremor-dominant Parkinson's disease.
- Subject should be stable on anti-Parkinson's disease medication for at least one month prior to study enrollment.
Exclusion Criteria:
Subjects will be excluded from the study if they meet any of the following criteria:
- Subject has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study.
- Subject has non-treated clinically significant depression or any other significant psychiatric co-morbidities.
- Subject has any condition requiring repeated MRI scans;
- Subject has any condition requiring diathermy;
- Subject is on anticoagulant medications and is unable to interrupt for time of procedure.
- Subject has a history of cranial surgery.
- Subject has dementia that interferes with their ability to co-operate or comply with study requirements or comprehend the Informed Consent as determined by the investigator.
- Subject abuses drugs or alcohol.
- Subject has a history of seizure
- Subject has confirmation of diagnosis of a terminal illness associated with survival <12 months.
- Female that is lactating or of childbearing potential with positive urine pregnancy test or not using adequate birth control.
- Subject has participated in a drug, device or biological trial within the preceding 30 days.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Kerstin Staeck / Clinical Project Leader - Neuromodulation, St. Jude Medical EMEAC |
| ClinicalTrials.gov Identifier: | NCT01352819 History of Changes |
| Other Study ID Numbers: | NM-09-036-EU-DB |
| Study First Received: | April 14, 2011 |
| Last Updated: | May 11, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices Germany: German Institute of Medical Documentation and Information Germany: Ethics Commission France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) France: Institutional Ethical Committee |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on May 21, 2013