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

NCT ID: NCT01352819

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 21 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-12-31

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.

Conditions

Parkinson's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Vesper, Prof

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinukum Dusseldorf

Locations

Hopital Neurologique

Lyon, , France

CHU Laennec

Nantes, , France

University Hospital Bonn

Bonn, , Germany

University Hospital of Duesseldorf

Düsseldorf, , Germany

University Hospital Regensburg

Regensburg, , Germany

Erciyes University Medicine School

Kayseri, , Turkey (Türkiye)

Countries

France; Germany; Turkey (Türkiye)

Other Identifiers

NM-09-036-EU-DB

Identifier Type: -

Identifier Source: org_study_id