Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease - Full Text View

Purpose

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.

Condition	Intervention
Parkinson Disease Movement Disorders	Device: Libra Deep Brain Stimulation System

Genetics Home Reference related topics:

familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics:

Movement Disorders Parkinson's Disease

ChemIDplus related topics:

Levodopa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study

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.

Further study details as provided by Advanced Neuromodulation Systems:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	136
Study Start Date:	October 2005
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: Placebo Comparator Implanted but no active stimulation	Device: Libra Deep Brain Stimulation System Implanted system but no stimulation
Group A: Experimental Active Stimulation	Device: Libra Deep Brain Stimulation System Active DBS Therapy

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552474

Contacts


Contact: PowerOverPD Call Center	1-888-859-0008

Locations


United States, California
	Loma Linda University School of Medicine	Recruiting
	Loma Linda, California, United States

United States, Illinois
	Rush University Medical Center	Recruiting
	Chicago, Illinois, United States

United States, Massachusetts
	Lahey Clinic	Recruiting
	Burlington, Massachusetts, United States

United States, Michigan
	Oakwood Hospital	Recruiting
	Dearborn, Michigan, United States

United States, New York
	Columbia University Medical Center	Recruiting
	New York, New York, United States
	Mount Sinai School of Medicine	Recruiting
	New York, New York, United States
	University of Rochester	Recruiting
	Rochester, New York, United States

United States, Ohio
	Mayfield Clinic	Recruiting
	Cincinnati, Ohio, United States

United States, Texas
	Neurology Specialists of Dallas	Recruiting
	Dallas, Texas, United States
	Baylor College of Medicine	Recruiting
	Houston, Texas, United States

United States, Virginia
	Univerisity of Virginia	Recruiting
	Charlottesville, Virginia, United States

United States, Wisconsin
	University of Wisconsin	Recruiting
	Madison, Wisconsin, United States

Sponsors and Collaborators

Advanced Neuromodulation Systems

Investigators


Study Director:	DeLea Peichel	ANS

More Information

Clinical Study specific web site This link exits the ClinicalTrials.gov site

ANS specific website This link exits the ClinicalTrials.gov site

Responsible Party:	Advanced Neuromodulation Systems, Inc ( DeLea Peichel/Director, Clinical Research )
Study ID Numbers:	C-04-01
First Received:	October 31, 2007
Last Updated:	April 23, 2008
ClinicalTrials.gov Identifier:	NCT00552474
Health Authority:	United States: Food and Drug Administration

Keywords provided by Advanced Neuromodulation Systems:

Parkinson disease

Movement disorders

Deep Brain Stimulation

Libra

l-dopa

levodopa

neuromodulation

neurostimulation

Electrical stimulation of the brain

STN

Subthalamic nucleus

Study placed in the following topic categories:

Levodopa

Ganglion Cysts

Movement Disorders

Parkinson Disease

Basal Ganglia Diseases

Dihydroxyphenylalanine

Central Nervous System Diseases

Parkinsonian Disorders

Neurodegenerative Diseases

Brain Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 07, 2008

Sponsored by:	Advanced Neuromodulation Systems
Information provided by:	Advanced Neuromodulation Systems
ClinicalTrials.gov Identifier:	NCT00552474