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Post Market (Libra/LibraXP System) Deep Brain Stimulation (DBS) Parkinson's Disease Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01352819
First received: April 14, 2011
Last updated: January 30, 2014
Last verified: January 2014
  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 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.


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

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Enrollment: 21
Study Start Date: May 2011
Study Completion Date: December 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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
Study Population

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.

Criteria

Inclusion Criteria:

Subjects enrolled in this study must meet the following inclusion criteria:

  1. Subject has signed an informed consent.
  2. Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease.
  3. Subject is a candidate for surgery.
  4. Subject is 18 to 80 years of age.
  5. 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.
  6. 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:

  1. Subject has any major illness or medical condition that in the opinion of the physician would interfere with participation in the study.
  2. Subject has non-treated clinically significant depression or any other significant psychiatric co-morbidities.
  3. Subject has any condition requiring repeated MRI scans;
  4. Subject has any condition requiring diathermy;
  5. Subject is on anticoagulant medications and is unable to interrupt for time of procedure.
  6. Subject has a history of cranial surgery.
  7. 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.
  8. Subject abuses drugs or alcohol.
  9. Subject has a history of seizure
  10. Subject has confirmation of diagnosis of a terminal illness associated with survival <12 months.
  11. Female that is lactating or of childbearing potential with positive urine pregnancy test or not using adequate birth control.
  12. Subject has participated in a drug, device or biological trial within the preceding 30 days.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352819

Locations
France
Hopital Neurologique
Lyon, France, 69003
CHU Laennec
Nantes, France, 44799
Germany
University Hospital Bonn
Bonn, Germany
University Hospital of Duesseldorf
Duesseldorf, Germany
University Hospital Regensburg
Regensburg, Germany, 93053
Turkey
Erciyes University Medicine School
Kayseri, Turkey
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Jan Vesper, Prof Universitätsklinukum Dusseldorf
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01352819     History of Changes
Other Study ID Numbers: NM-09-036-EU-DB
Study First Received: April 14, 2011
Last Updated: January 30, 2014
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
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders

ClinicalTrials.gov processed this record on November 25, 2014