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

April 17, 2026 updated by: University Hospital, Lille

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

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • CHU Hopital Nord
      • Bron, France
        • Hôpital Pierre Wertheimer
      • Clermont-Ferrand, France
        • CHU Gabriel-Montpied
      • Lille, France, 59037
        • Devos
      • Marseille, France
        • Hopital de la Timone
      • Nancy, France
        • Hôpital Central,
      • Nantes, France
        • CHU hôpital Nord Laennec
      • Nice, France
        • Hopital PASTEUR
      • Paris, France
        • Hopital Pitie Salpetriere
      • Paris, France
        • Fondation Ophtalmologique Adolphe de Rothschild
      • Poitiers, France
        • CHU De Poitiers
      • Rennes, France
        • CHU Hôpital Pontchaillou
      • Rouen, France
        • Chu Ch.Nicolle
      • Strasbourg, France
        • Hopital de Hautepierre
      • Toulouse, France
        • CHU Purpan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

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

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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 Names:
  • systematic and standardized collection of data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Improve of quality of life on PDQ39>20%
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of motor score MDS-UPDRS III improve under stimulation
Time Frame: 1 year
1 year
Socio-familial evolution (institutionalization)
Time Frame: 1, 3 and 5 years
1, 3 and 5 years
Clinical Global Impression of Patient by 7-point scale
Time Frame: 1, 3 and 5 years
with the CGI-scale
1, 3 and 5 years
Clinical Global Impression of doctor by 7-point scale
Time Frame: 1, 3 and 5 years
with the CGI-scale
1, 3 and 5 years
Death
Time Frame: 1, 3 and 5 years
1, 3 and 5 years
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
1, 3 and 5 years
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
1, 3 and 5 years
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
1, 3 and 5 years
Non-motor functions evaluated by a numerical evaluation scale
Time Frame: screening and at 1, 3 and 5 years
screening and at 1, 3 and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Ministry of Health, France

Investigators

  • Study Chair: David DEVOS, MD, PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2013

Primary Completion (Actual)

October 10, 2025

Study Completion (Actual)

October 10, 2025

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

February 5, 2015

First Posted (Estimated)

February 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011_41
  • 2013-A00193-42 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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