Predictive Factors and Subthalamic Stimulation in Parkinson's Disease (PREDI-STIM)

University Hospital, Lille

Status: Active, not recruiting

Conditions: Parkinson's Disease

Treatments: Other: patients with Parkinson's disease

Study type: Observational

Funder types: Other

Identifiers

NCT02360683

2011_41

2013-A00193-42 (Other Identifier)

Details and patient eligibility

About

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 .

Enrollment: 700 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

700 participants in 1 patient group

patients with Parkinson's disease

Description:

Large population of Parkinson's patients who benefit from subthalamic stimulation

Treatment:

Other: patients with Parkinson's disease