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

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease

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.

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • Hôpital neurologique
  • Nantes, France, 44799
    • CHU Laennec
• Germany
  • Bonn, Germany
    • University Hospital Bonn
  • Duesseldorf, Germany
    • University Hospital of Duesseldorf
  • Regensburg, Germany, 93053
    • University Hospital Regensburg
• Turkey
  • Kayseri, Turkey
    • Erciyes University Medicine School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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].

Secondary Outcome Measures

Outcome Measure	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	[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]

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Jan Vesper, Prof, Universitätsklinukum Dusseldorf

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: April 14, 2011
• First Submitted That Met QC Criteria: May 11, 2011
• First Posted (Estimate): May 12, 2011

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: NM-09-036-EU-DB