Predictive Factors and Subthalamic Stimulation in Parkinson’s Disease

Overview

This study identify preoperative predictors of response to subthalamic stimulation at 1 year, 3 years and 5 years in terms of quality of life, from a broad prospective multicenter study French with standardized collection of clinical data , imaging and genetic .

The investigators want to identify factors that predict the improvement of quality of life for one year corresponding to a decrease of PDQ39 score of at least 20 %. They believe that improvement would be less likely to become zero to 3 or 5 years and question the indication of the subthalamic stimulation (risks and costs). This is part of a process of "personalization" of the therapeutic care that is of any interest to the subthalamic stimulation. It is a therapeutic option that could be dangerous if patient selection is not optimal , and expensive, if the benefit is not large enough to reduce the number of medications and hospitalizations medium term . In addition, it will quantify the improvement of quality of life in the longer term and harmonize national assessments .

Full Title of Study: “Predictive Factors for Therapeutic Response of Subthalamic Stimulation on Quality of Live in Parkinson’s Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 2019

Interventions

  • Other: patients with Parkinson’s disease

Arms, Groups and Cohorts

  • patients with Parkinson’s disease
    • Large population of Parkinson’s patients who benefit from subthalamic stimulation

Clinical Trial Outcome Measures

Primary Measures

  • Improve of quality of life on PDQ39>20%
    • Time Frame: 1 year

Secondary Measures

  • Percentage of motor score MDS-UPDRS III improve under stimulation
    • Time Frame: 1 year
  • Socio-familial evolution (institutionalization)
    • Time Frame: 1, 3 and 5 years
  • Clinical Global Impression of Patient by 7-point scale
    • Time Frame: 1, 3 and 5 years
    • with the CGI-scale
  • Clinical Global Impression of doctor by 7-point scale
    • Time Frame: 1, 3 and 5 years
    • with the CGI-scale
  • Death
    • Time Frame: 1, 3 and 5 years
  • Cognitive function with a neuropsychological examination
    • Time Frame: 1, 3 and 5 years
    • with Mattis scale, Wisconsin Card Sorting test, Stroop test, , verbal episodic memory test with 16 items, phonemic and semantic verbal fluency, Boston naming test (15 items), clock drawing and Benton line orientation task
  • Behavior test
    • Time Frame: 1, 3 and 5 years
    • ECMP scale of Ardouin 2009, Hamilton depression scale, Anxiety Hamilton scale, Lille Apathy Rating Scale, QUIP questionnaire, Billieux Impulsivity Scale, Hallucination questionnaire of Miami
  • Motor response rates to Levodopa
    • Time Frame: 1, 3 and 5 years
    • with the difference of the motor handicap measured by MDS UPDRS part III before and after an acute L-dopa challenge
  • Non-motor functions evaluated by a numerical evaluation scale
    • Time Frame: screening and at 1, 3 and 5 years

Participating in This Clinical Trial

Inclusion Criteria

  • Patients receiving a pre- therapeutic assessment and therapeutic monitoring for one year , 3 years and 5 years as part of the regular monitoring of the subthalamic stimulation
  • Bilateral STN stimulation considered
  • Patient able to provide their free and informed consent
  • Patient with insurance coverage

Exclusion Criteria

  • Atypical Parkinson's disease do not meet the criteria of stuff .
  • MP under 5 years
  • Severe cognitive impairment or dementia ( Score Moca <24 and DSM-IV criteria)
  • Parkinson's Psychosis
  • Reply to L- dopa <30 %
  • Against indication for surgery
  • Severe brain atrophy or abnormal MRI
  • The presence of another very serious condition terminal life- short-term prognosis ( malignancy ) is an indication against .

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Lille
  • Collaborator
    • Ministry of Health, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • David DEVOS, MD, PhD, Study Chair, University Hospital, Lille
  • Overall Contact(s)
    • David DEVOS, MD,PhD, +33320446752, david.devos@chru-lille.fr

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