Skip to main content
OpenTrials
Completed

NCT Number: NCT00552474

Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Libra Deep Brain Stimulation System

Device

Active DBS Therapy

Primary outcomes

  1. Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias

    Time frame: 90 days

Secondary outcomes

  1. 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

Other outcomes

  1. Efficacy

    Time frame: Yearly for 5 years

    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.

  2. Quality of life

    Time frame: up to to 5 years

    Quality of Life measurements as measured by the Parkinson's Disease Questionnaire (PDQ 39)

  3. Activites of Daily Living

    Time frame: up to 5 years

    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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study 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.

Important dates

Study start
2005
Primary completion
2010
Study completion
2016
First posted
Nov 2, 2007
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.