Parkinson's Disease
Conditions
Keywords
Subthalamic neurostimulation
Brief summary
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 .
Interventions
Sponsors
University Hospital, Lille
Ministry of Health, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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 .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improve of quality of life on PDQ39>20% | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of motor score MDS-UPDRS III improve under stimulation | 1 year | — |
| Socio-familial evolution (institutionalization) | 1, 3 and 5 years | — |
| Clinical Global Impression of Patient by 7-point scale | 1, 3 and 5 years | with the CGI-scale |
| Clinical Global Impression of doctor by 7-point scale | 1, 3 and 5 years | with the CGI-scale |
| Death | 1, 3 and 5 years | — |
| Cognitive function with a neuropsychological examination | 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 | 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 | 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 | screening and at 1, 3 and 5 years | — |
Countries
France
Contacts
STUDY_CHAIRDavid DEVOS, MD, PhD
University Hospital, Lille
Outcome results
None listed