Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Advanced Neuromodulation Systems

ClinicalTrials.gov Identifier:

NCT00552474

First received: October 31, 2007

Last updated: October 10, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 31, 2007

Last Updated Date

October 10, 2012

Start Date ^ICMJE

October 2005

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias [ Time Frame: 90 days ]

Change History

Complete list of historical versions of study NCT00552474 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease

Official Title ^ICMJE

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.

Brief 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.

This is a prospective, controlled, multi-centered, 12 months post-implantation study. A maximum of 12 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 satisfaction scoring.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Parkinson Disease
Movement Disorders

Intervention ^ICMJE

Device: Libra Deep Brain Stimulation System
Active DBS Therapy

Other Name: Libra Deep Brain Stimulation System
Device: Libra Deep Brain Stimulation System
Implanted system but no stimulation

Other Name: Libra Deep Brain Stimulation System

Study Arm (s)

Placebo Comparator: Group B
Implanted but no active stimulation

Intervention: Device: Libra Deep Brain Stimulation System
Experimental: Group A
Active Stimulation

Intervention: Device: Libra Deep Brain Stimulation System

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

136

Completion Date

October 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00552474

Other Study ID Numbers ^ICMJE

C-04-01

Has Data Monitoring Committee

Yes

Responsible Party

Advanced Neuromodulation Systems

Study Sponsor ^ICMJE

Advanced Neuromodulation Systems

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

DeLea Peichel

ANS

Information Provided By

Advanced Neuromodulation Systems

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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