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Deep Brain Stimulation for Patients With Parkinson's Disease.

Completed
Conditions
Parkinson Disease
Registration Number
NCT03128567
Lead Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
10
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
PDQ-39 Quality of life questionnaryQuality of life one year after surgery

PDQ-39 scale

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (7)

Service d'EFSN, Hôpital Pellegrin

🇫🇷

Bordeaux, France

Hôpital Roger Salengro - CHRU de Lille Service de Neurologie et Pathologie du Mouvement

🇫🇷

Lille, France

Hôpital Neurologique Pierre Wertheimer, Service de Neurologie

🇫🇷

Lyon, France

Département des maladies du Système Nerveux, Hôpital Pitié-Salpétrière

🇫🇷

Paris, France

Service de Neurologie, Pôle Neurosciences, CHU de Poitiers

🇫🇷

Poitiers, France

CHU Charles Nicolle

🇫🇷

Rouen, France

Centre d'Investigation Clinique - CIC 1436. CHU PURPAN. Hôpital Pierre Paul Riquet

🇫🇷

Toulouse, France

Service d'EFSN, Hôpital Pellegrin
🇫🇷Bordeaux, France

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