Deep Brain Stimulation for Patients With Parkinson's Disease.
STTARTLATE
Effets de la Stimulation cérébrale Profonde Chez Les Patients âgés Avec Maladie de Parkinson : Essai contrôlé randomisé Multicentrique
1 other identifier
observational
10
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2017
Typical duration for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2017
CompletedFirst Posted
Study publicly available on registry
April 25, 2017
CompletedStudy Start
First participant enrolled
November 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 6, 2020
CompletedMay 22, 2025
May 1, 2025
2.2 years
February 23, 2017
May 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
PDQ-39 Quality of life questionnary
PDQ-39 scale
Quality of life one year after surgery
Study Arms (2)
Stimulation of the subthalamic nucleus
25 patients with Parkinson's disease
Best medical treatment
25 patients with Parkinson's disease
Interventions
Stimulation of the subthalamic nucleus
Eligibility Criteria
Parkinson's disease
You may qualify if:
- Parkinson's disease
- disease duration \> 5 years
- levodopa related motor complications
- dopasensitivity \> 50%
- signed informed written consent
- medical social insurance
You may not qualify if:
- dementia
- contra-indication to neurosurgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Service d'EFSN, Hôpital Pellegrin
Bordeaux, 33076, France
Hôpital Roger Salengro - CHRU de Lille Service de Neurologie et Pathologie du Mouvement
Lille, 59037 Lille Cedex, France
Hôpital Neurologique Pierre Wertheimer, Service de Neurologie
Lyon, 69677 Bron cedex, France
Département des maladies du Système Nerveux, Hôpital Pitié-Salpétrière
Paris, 75013, France
Service de Neurologie, Pôle Neurosciences, CHU de Poitiers
Poitiers, 86021 Poitiers cedex, France
CHU Charles Nicolle
Rouen, 76000, France
Centre d'Investigation Clinique - CIC 1436. CHU PURPAN. Hôpital Pierre Paul Riquet
Toulouse, 31059 Toulouse Cedex 9, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2017
First Posted
April 25, 2017
Study Start
November 27, 2017
Primary Completion
February 6, 2020
Study Completion
February 6, 2020
Last Updated
May 22, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share