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Deep Brain Stimulation for Patients With Parkinson's Disease.

Completed
Conditions
Parkinson Disease
Interventions
Device: Stimulation of the subthalamic nucleus
Registration Number
NCT03128567
Lead Sponsor
Institut National de la Sant茅 Et de la Recherche M茅dicale, 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
Arm && Interventions
GroupInterventionDescription
Stimulation of the subthalamic nucleusStimulation of the subthalamic nucleus25 patients with Parkinson's disease
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, H么pital Pellegrin

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Bordeaux, France

H么pital Roger Salengro - CHRU de Lille Service de Neurologie et Pathologie du Mouvement

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Lille, France

H么pital Neurologique Pierre Wertheimer, Service de Neurologie

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Lyon, France

D茅partement des maladies du Syst猫me Nerveux, H么pital Piti茅-Salp茅tri猫re

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Paris, France

Service de Neurologie, P么le Neurosciences, CHU de Poitiers

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Poitiers, France

CHU Charles Nicolle

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Rouen, France

Centre d'Investigation Clinique - CIC 1436. CHU PURPAN. H么pital Pierre Paul Riquet

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Toulouse, France

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