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Official Study Title: A Clinical  ClinicalDealing with or based on observation and treatment of people, as opposed to basic science carried out in the laboratory or in animals. Evaluation of bilateral  BilateralBoth sides of the body. stimulation of the subthalamic nucleus (STN) using the ANS Totally Implantable Deep Brain Stimulation  Deep Brain Stimulation (DBS)Procedure in which a small, surgically implanted, battery-operated medical device delivers electrical stimulation, and "turns-off" brain regions that produce Parkinson’s symptoms. System as an adjunctive treatment for reducing some of the symptoms of advanced, levodopa-responsive PD
Sponsor: Advanced Neuromodulation Systems, a St. Jude Medical Company
Clinicaltrials.gov ID: NCT00552474
Study ID: C-04-01 Libra

Summary

The purpose of this study is to evaluate the safety and efficacy  EfficacyThe extent to which a specific intervention, procedure, or regimen produces a beneficial result under ideal conditions. of bilateral stimulation of a certain part of the brain called the subthalamic nucleus (STN) when using the ANS Totally Implantable Deep Brain Stimulation System as an adjunctive treatment for reducing some of the symptoms of Parkinson's Disease  Parkinson's DiseaseA chronic, slowly progressive disease of the nervous system characterized by the combination of tremor, rigidity, bradykinesia and stooped posture, among other symptoms. (PD) that are not adequately controlled with medication.

A maximum of 12 sites will enroll a total of 136 participants in this study. 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,  BaselinBeginning measurements against which a participant’s progress can be quantified at the end of a study. three, six and twelve month visits the participant's PD symptoms and ability to perform daily activities will be evaluated using a number of accepted assessment tools including a Dyskinesia  DyskinesiaTwisting, turning or other abnormal involuntary movement usually involving the arms, legs, trunk, and head. It is most commonly associated with long-term use of levodopa. (uncontrollable movements) diary, evaluation of PD symptoms, quality of life scoring and participant satisfaction scoring.

Study Phase

Phase 3
What is a study phase?

Symptoms Addressed: Movement and Non-movement

Walking/Gait,  GaitWay of walking, which is diminished in people with Parkinson’s who tend to shuffle their feet, take too short steps, and not swing one or both arms. Uncontrollable movements (Dyskinesia), Tremor,  TremorShaking or rhythmic movement, especially in the hands but in other parts of the body. Often occurs when at rest, such as in the RESTING TREMOR. Slowness of movement (bradykinesia)  BradykinesiaSlowness of movement. , Sleep disturbances, Rigidity,  RigidityA symptom in which muscles feel stiff and display resistance to movement even when another person tries to move the affected part of the body. Loss of Motor Skills, General PD symptoms, Balance

Time Commitment

• More than six months
• One baseline pre-surgery visit, inpatient surgery, post-surgery follow-up visit, one follow-up visit at 30 days, one follow-up visit at 3 months, one follow-up visit at 6 months, one follow-up visit at 12 months.

Eligibility

• Minimum Age: 18
• Maximum Age: 80
• Gender(s) Accepted: Either
• Minimum Years Since Diagnosis: 5

Inclusion Criteria

• Persons of ages 18 to 80, who have been diagnosed with PD for at least five years
• Person experiences at least six 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)  LevodopaA compound that is converted into dopamine (the brain chemical which is deficient in people with Parkinson's) in the brain. 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
• Person has a history of drug or alcohol abuse

Enrollment

Expected Enrollment: 136 (US)
Date Enrollment Began: Oct 01 2005
Last Updated Date: Oct 24 2007
Trial Post Date: Oct 24 2007
Website: http://www.PowerOverParkinsons.com

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