NCT01352819

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 21 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-03-01
• Completion: 2013-12-01
• First posted: 2011-05-12
• Last updated: 2022-11-09

Locations

6 sites across 3 countries: France, Germany, Turkey (Türkiye)