Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease

NCT ID: NCT00552474

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 136 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2016-11-30

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.

Detailed 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.

Conditions

Parkinson Disease; Movement Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group B

Implanted but no active stimulation

Group Type: PLACEBO_COMPARATOR

Libra Deep Brain Stimulation System

Intervention Type: DEVICE

Implanted system but no stimulation

Group A

Active Stimulation

Group Type: EXPERIMENTAL

Libra Deep Brain Stimulation System

Intervention Type: DEVICE

Active DBS Therapy

Interventions

Libra Deep Brain Stimulation System

Active DBS Therapy

Intervention Type: DEVICE

Libra Deep Brain Stimulation System

Implanted system but no stimulation

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

DeLea Peichel

Role: STUDY_DIRECTOR

ANS/St Jude Medical

Locations

Loma Linda University School of Medicine

Loma Linda, California, United States

University of Florida

Gainesville, Florida, United States

Universtiy of Miami

Miami, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Lahey Clinic

Burlington, Massachusetts, United States

Oakwood Hospital

Dearborn, Michigan, United States

Mount Sinai School of Medicine

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Mayfield Clinic

Cincinnati, Ohio, United States

Pennsylvania Hospital (UPHS)

Philadelphia, Pennsylvania, United States

Neurology Specialists of Dallas

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Univerisity of Virginia

Charlottesville, Virginia, United States

Medical College of Wisconcin

Milwaukee, Wisconsin, United States

Countries

United States

References

Okun MS, Gallo BV, Mandybur G, Jagid J, Foote KD, Revilla FJ, Alterman R, Jankovic J, Simpson R, Junn F, Verhagen L, Arle JE, Ford B, Goodman RR, Stewart RM, Horn S, Baltuch GH, Kopell BH, Marshall F, Peichel D, Pahwa R, Lyons KE, Troster AI, Vitek JL, Tagliati M; SJM DBS Study Group. Subthalamic deep brain stimulation with a constant-current device in Parkinson's disease: an open-label randomised controlled trial. Lancet Neurol. 2012 Feb;11(2):140-9. doi: 10.1016/S1474-4422(11)70308-8. Epub 2012 Jan 11.

Reference Type: DERIVED

PMID: 22239915 (View on PubMed)

Related Links

http://www.ans-medical.com

ANS specific website

Other Identifiers

C-04-01

Identifier Type: -

Identifier Source: org_study_id