Deep Brain Stimulation for Patients With Parkinson's Disease. (STTARTLATE)

May 19, 2025 updated by: Institut National de la Santé Et de la Recherche Médicale, France

Effets de la Stimulation cérébrale Profonde Chez Les Patients âgés Avec Maladie de Parkinson : Essai contrôlé randomisé Multicentrique

Deep brain stimulation of the sub thalamic nucleus (STN-DBS) is an efficient treatment to improve motor and non motor signs of Parkinson's disease (PD). In people aged more 70 years, an increased rate of side effects such as post-operative cognitive decline and/or postural instability with falls has been suspected with less improvement in the quality of life. Here, Investigators aim further explore the effects of STN-DBS in 50 patients with PD people aged more 69 years in a randomized parallel controlled study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The effects of combined bilateral deep brain stimulation of the subthalamic nucleus and medical treatment on the quality of life will be evaluated in 25 PD patients aged more 69 years in comparison to 25 PD patients aged more 69 years that only received medical drug treatment.

Study Type

Observational

Enrollment (Actual)

10

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
      • Bordeaux, France, 33076
        • Service d'EFSN, Hôpital Pellegrin
      • Lille, France, 59037 Lille Cedex
        • Hôpital Roger Salengro - CHRU de Lille Service de Neurologie et Pathologie du Mouvement
      • Lyon, France, 69677 Bron cedex
        • Hôpital Neurologique Pierre Wertheimer, Service de Neurologie
      • Paris, France, 75013
        • Département des maladies du Système Nerveux, Hôpital Pitié-Salpétrière
      • Poitiers, France, 86021 Poitiers cedex
        • Service de Neurologie, Pôle Neurosciences, CHU de Poitiers
      • Rouen, France, 76000
        • CHU Charles Nicolle
      • Toulouse, France, 31059 Toulouse Cedex 9
        • Centre d'Investigation Clinique - CIC 1436. CHU PURPAN. Hôpital Pierre Paul Riquet

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

69 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Parkinson's disease

Description

Inclusion Criteria:

  • Parkinson's disease
  • disease duration > 5 years
  • levodopa related motor complications
  • dopasensitivity > 50%
  • signed informed written consent
  • medical social insurance

Exclusion Criteria:

  • dementia
  • contra-indication to neurosurgery

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
Stimulation of the subthalamic nucleus
25 patients with Parkinson's disease
Device: Stimulation of the subthalamic nucleus
Stimulation of the subthalamic nucleus
Best medical treatment
25 patients with Parkinson's disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PDQ-39 Quality of life questionnary
Time Frame: Quality of life one year after surgery
PDQ-39 scale
Quality of life one year after surgery

Collaborators and Investigators

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

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France

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 27, 2017

Primary Completion (Actual)

February 6, 2020

Study Completion (Actual)

February 6, 2020

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

April 20, 2017

First Posted (Actual)

April 25, 2017

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C 14-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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