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

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT01352819
• Lead Sponsor: Abbott Medical Devices

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-04-14
• Study Start: 2011-05
• Study First Submitted QC: 2011-05-11
• Study First Posted: 2011-05-12
• Primary Completion: 2013-03
• Study Completion: 2013-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
UPDRS motor scores	[Time Frame: 3 months after device implantation].	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

Name	Time	Method
Satisfaction of therapy	[through 3, 6 months and 1 year]	Rate of subject and caregivers therapy satisfaction through 3, 6 month and 1 year
Economic burden of the disease	[at baseline and 1 year]	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)	[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]

Trial Locations

Locations (6)

Erciyes University Medicine School; 🇹🇷 Kayseri, Turkey

Hopital Neurologique; 🇫🇷 Lyon, France

University Hospital Regensburg; 🇩🇪 Regensburg, Germany

CHU Laennec; 🇫🇷 Nantes, France

University Hospital of Duesseldorf; 🇩🇪 Duesseldorf, Germany

University Hospital Bonn; 🇩🇪 Bonn, Germany