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Trial record 5 of 8 for:    DEVOS | Parkinson | France

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

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ClinicalTrials.gov Identifier: NCT02360683
Recruitment Status : Recruiting
First Posted : February 10, 2015
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Lille

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 .


Condition or disease Intervention/treatment
Parkinson's Disease Other: patients with Parkinson's disease

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Factors for Therapeutic Response of Subthalamic Stimulation on Quality of Live in Parkinson's Disease
Actual Study Start Date : November 18, 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
patients with Parkinson's disease
Large population of Parkinson's patients who benefit from subthalamic stimulation
Other: patients with Parkinson's disease
Other Name: systematic and standardized collection of data




Primary Outcome Measures :
  1. Improve of quality of life on PDQ39>20% [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Percentage of motor score MDS-UPDRS III improve under stimulation [ Time Frame: 1 year ]
  2. Socio-familial evolution (institutionalization) [ Time Frame: 1, 3 and 5 years ]
  3. Clinical Global Impression of Patient by 7-point scale [ Time Frame: 1, 3 and 5 years ]
    with the CGI-scale

  4. Clinical Global Impression of doctor by 7-point scale [ Time Frame: 1, 3 and 5 years ]
    with the CGI-scale

  5. Death [ Time Frame: 1, 3 and 5 years ]
  6. 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

  7. 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

  8. 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

  9. Non-motor functions evaluated by a numerical evaluation scale [ Time Frame: screening and at 1, 3 and 5 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Multicentric French cohort of 1000 Parkinson's disease patients, for obtain 400 patients in the failure group
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02360683


Contacts
Contact: David DEVOS, MD,PhD +33320446752 ext +33 david.devos@chru-lille.fr

Locations
France
CHU Hôpital NORD Recruiting
Amiens, France
Principal Investigator: Pierre Krystkowiak, MD,PhD         
Hôpital Pierre Wertheimer Recruiting
Bron, France
Principal Investigator: Stéphane Thobois, MD,PhD         
Chu Gabriel-Montpied Recruiting
Clermont-Ferrand, France
Principal Investigator: Franck Durif, MD,PhD         
Devos Recruiting
Lille, France, 59037
Contact: David Devos, MD, PhD    +33320446752    david.devos@chru-lille.fr   
Contact: Francine Niset    +33320446752    francine.niset@chru-lille.fr   
Sub-Investigator: caroline Moreau, MD, PhD         
Hôpital de la Timone Recruiting
Marseille, France
Principal Investigator: Alexandre Eusebio, MD         
Hôpital Central, Recruiting
Nancy, France
Principal Investigator: Lucies Hopes, MD         
CHU hôpital Nord Laennec Recruiting
Nantes, France
Principal Investigator: Tiphaine Rouaud, MD         
Hôpital Pasteur Recruiting
Nice, France
Principal Investigator: Caroline Giordana, MD         
Fondation Ophtalmologique Adolphe de Rothschild Recruiting
Paris, France
Principal Investigator: Cécile HUBSCH, MD         
Hopital Pitie Salpetriere Recruiting
Paris, France
Principal Investigator: Marie Laure Marie Laure Welter, MD         
CHU de Poitiers Recruiting
Poitiers, France
Principal Investigator: Jean-Luc Houeto, MD,Phd         
CHU Hôpital Pontchaillou Recruiting
Rennes, France
Principal Investigator: Sophie Drapier, MD         
Chu Ch.Nicolle Recruiting
Rouen, France
Principal Investigator: David Maltete, MD,PhD         
Hôpital de Hautepierre Recruiting
Strasbourg, France
Principal Investigator: Christine Tranchant, MD,PhD         
CHU Purpan Recruiting
Toulouse, France
Principal Investigator: Olivier Rascol, MD, PhD         
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
Study Chair: David DEVOS, MD, PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02360683     History of Changes
Other Study ID Numbers: 2011_41
2013-A00193-42 ( Other Identifier: ID-RCB number, ANSM )
First Posted: February 10, 2015    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
Subthalamic neurostimulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases