Predictive Factors and Subthalamic Stimulation in Parkinson's Disease

Parkinson's Disease Clinical Trial

— PREDI-STIM  

Official title:

Predictive Factors for Therapeutic Response of Subthalamic Stimulation on Quality of Live in Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02360683
• Other study ID #: 2011_41
• Secondary ID: 2013-A00193-42
• Status: Active, not recruiting
• Start date: November 18, 2013
• Est. completion date: November 2025

Study information

• Verified date: November 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: November 2025
• Est. primary completion date: November 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• patients with Parkinson's disease

Locations

Country	Name	City	State
France	CHU Hôpital NORD	Amiens
France	Hôpital Pierre Wertheimer	Bron
France	Chu Gabriel-Montpied	Clermont-Ferrand
France	Devos	Lille
France	Hôpital de la Timone	Marseille
France	Hôpital Central,	Nancy
France	CHU hôpital Nord Laennec	Nantes
France	Hôpital Pasteur	Nice
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	Hopital Pitie Salpetriere	Paris
France	CHU de Poitiers	Poitiers
France	CHU Hôpital Pontchaillou	Rennes
France	Chu Ch.Nicolle	Rouen
France	Hôpital de Hautepierre	Strasbourg
France	CHU Purpan	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve of quality of life on PDQ39>20%		1 year
Secondary	Percentage of motor score MDS-UPDRS III improve under stimulation		1 year
Secondary	Socio-familial evolution (institutionalization)		1, 3 and 5 years
Secondary	Clinical Global Impression of Patient by 7-point scale	with the CGI-scale	1, 3 and 5 years
Secondary	Clinical Global Impression of doctor by 7-point scale	with the CGI-scale	1, 3 and 5 years
Secondary	Death		1, 3 and 5 years
Secondary	Cognitive function with a neuropsychological examination	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	1, 3 and 5 years
Secondary	Behavior test	ECMP scale of Ardouin 2009, Hamilton depression scale, Anxiety Hamilton scale, Lille Apathy Rating Scale, QUIP questionnaire, Billieux Impulsivity Scale, Hallucination questionnaire of Miami	1, 3 and 5 years
Secondary	Motor response rates to Levodopa	with the difference of the motor handicap measured by MDS UPDRS part III before and after an acute L-dopa challenge	1, 3 and 5 years
Secondary	Non-motor functions evaluated by a numerical evaluation scale		screening and at 1, 3 and 5 years