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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02360683
Recruitment Status : Active, not recruiting
First Posted : February 10, 2015
Last Update Posted : March 26, 2020
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

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Study Type : Observational
Actual Enrollment : 700 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
Actual Primary Completion Date : November 2019
Estimated Study Completion Date : November 2025

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 ]


Information from the National Library of Medicine

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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


Locations
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France
CHU Hôpital NORD
Amiens, France
Hôpital Pierre Wertheimer
Bron, France
Chu Gabriel-Montpied
Clermont-Ferrand, France
Devos
Lille, France, 59037
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, France
Sponsors and Collaborators
University Hospital, Lille
Ministry of Health, France
Investigators
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Study Chair: David DEVOS, MD, PhD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02360683    
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: March 26, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases