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Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00552474
First received: October 31, 2007
Last updated: February 22, 2017
Last verified: February 2017
October 31, 2007
February 22, 2017
October 2005
October 2010   (Final data collection date for primary outcome measure)
Increase the duration of "on time" without dyskinesias or with non-bothersome dyskinesias [ Time Frame: 90 days ]
Same as current
Complete list of historical versions of study NCT00552474 on ClinicalTrials.gov Archive Site
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 ]
Same as current
  • 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.
  • Quality of life [ Time Frame: up to to 5 years ]
    Quality of Life measurements as measured by the Parkinson's Disease Questionnaire (PDQ 39)
  • 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
Not Provided
 
Deep Brain Stimulation to Treat Symptoms of Parkinson's Disease
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.
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 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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
  • Parkinson Disease
  • Movement Disorders
  • Device: Libra Deep Brain Stimulation System
    Active DBS Therapy
  • Device: Libra Deep Brain Stimulation System
    Implanted system but no stimulation
  • 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
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, Tröster 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. Erratum in: Lancet Neurol. 2012 Mar;11(3):208.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
November 2016
October 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00552474
C-04-01
Yes
Not Provided
Not Provided
Not Provided
St. Jude Medical
St. Jude Medical
Not Provided
Study Director: DeLea Peichel ANS/St Jude Medical
St. Jude Medical
February 2017

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