Overview

This trial is active, not recruiting.

Conditions parkinson disease, movement disorders
Treatments libra deep brain stimulation system
Sponsor Advanced Neuromodulation Systems
Start date October 2005
End date October 2010
Trial size 136 participants
Trial identifier NCT00552474, C-04-01

Summary

The purpose of this study is to evaluate the safety and efficacy of bilateral stimulation of the subthalamic nucleus (STN) of the brain when using the ANS Totally Implantable Deep Brain Stimulation System as an adjunctive treatment for reducing some of the symptoms of Parkinson's Disease that are not adequately controlled with medication.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Placebo Comparator)
Implanted but no active stimulation
libra deep brain stimulation system Libra Deep Brain Stimulation System
Implanted system but no stimulation
(Experimental)
Active Stimulation
libra deep brain stimulation system Libra Deep Brain Stimulation System
Active DBS Therapy

Primary Outcomes

Measure
Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias
time frame: 90 days

Secondary Outcomes

Measure
Changes in the following over time: Incidence of AEs; UPDRS motor scores; Activities of Daily Living; Quality of Life, Quality Sleep Index, Hoehn and Yahr Staging, Global Outcome evaluation and Patient Satisfaction
time frame: 1 year

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Person is 18 to 80 years of age - Person has been diagnosed with Parkinson's disease for at lease five (5) years - Person experiences at least six (6) hours or more daily "off-time" or moderate to severe dyskinesias during waking hours - Person has a history of improvement of Parkinson's symptoms with l-dopa (levodopa) therapy - Person must be willing to maintain a constant dose of anti-Parkinson's disease medication for at least one month prior to study enrollment - Person must be available for appropriate follow-up times for the length of the study Exclusion Criteria: - Person has any major illness or medical condition that would interfere with participation in the study - Person currently suffers from untreated, major depression - Person has an electrical or electromagnetic implant (e.g. cochlear prosthesis or pacemaker) - Person has had a prior surgery for the treatment of PD symptoms, including previous DBS surgery - Person has dementia - Person has a history of seizures

Additional Information

Official title A Clinical Evaluation of Bilateral Stimulation of the Subthalamic Nucleus (STN) Using the ANS Totally Implantable Deep Brain Stimulation System as an Adjunctive Treatment for Reducing Some of the Symptoms of Advanced, Levodopa-responsive Parkinson's Disease That Are Not Adequately Controlled With Medication.
Description This is a prospective, controlled, multi-centered, 12 months post-implantation study. A maximum of 15 sites will enroll a total of 136 patients. All study participants will have the study device surgically implanted. After implant surgery, study participants will return to the clinic for evaluation 30 days after surgery, three months after surgery, six months after surgery and twelve months after surgery. At the baseline, three, six and twelve month visits the patient's Parkinson's symptoms and ability to perform daily activities will be evaluated using a number of accepted assessment tools including a Dyskinesia diary, evaluation of PD symptoms, quality of life scoring and patient extension study to monitor the safety and efficacy of the ANS Libra/Libra Deep Brain Stimulation System. After the 1 year study, patients may enter another protocol (C-06-04) to continue to monitor the safety and efficacy of the Libra Deep Brain Stimulation System. Patients may be followed for an additional 4 years. If necessary, patients may continue to have access to the investigational device under protocol (C-13-02) which allows for compassionate use access to it.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Advanced Neuromodulation Systems.