Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease

Parkinson Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552474
• Other study ID #: C-04-01
• Status: Completed
• Phase: N/A
• Start date: October 2005
• Est. completion date: November 2016

Study information

• Verified date: January 2019
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: November 2016
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Movement Disorders
• Parkinson Disease

Intervention

Device:
• Libra Deep Brain Stimulation System
Active DBS Therapy
• Libra Deep Brain Stimulation System
Implanted system but no stimulation

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts
United States	Univerisity of Virginia	Charlottesville	Virginia
United States	Rush University Medical Center	Chicago	Illinois
United States	Mayfield Clinic	Cincinnati	Ohio
United States	Neurology Specialists of Dallas	Dallas	Texas
United States	Oakwood Hospital	Dearborn	Michigan
United States	University of Florida	Gainesville	Florida
United States	Baylor College of Medicine	Houston	Texas
United States	Loma Linda University School of Medicine	Loma Linda	California
United States	Universtiy of Miami	Miami	Florida
United States	Medical College of Wisconcin	Milwaukee	Wisconsin
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Pennsylvania Hospital (UPHS)	Philadelphia	Pennsylvania
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Efficacy	Reduction in Parkinson's symptoms as demonstrated by the total UPDRS scores and each individual component of the UPDRS in the medication on and off state with stimulation on at 2 years, 3 years, 4 years, and 5 years.	Yearly for 5 years
Other	Quality of life	Quality of Life measurements as measured by the Parkinson's Disease Questionnaire (PDQ 39)	up to to 5 years
Other	Activites of Daily Living	Activities of Daily Living measurement at 2 years, 3 years, 4 years, and 5 years as determined from the Unified Parkinson's Disease Rating Scale (UPDRS) in the medication on and stimulation on state	up to 5 years
Primary	Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias		90 days
Secondary	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		1 year

External Links

•   ANS specific website