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Clinical Trials/NCT03128567
NCT03128567
Completed
N/A

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

Institut National de la Santé Et de la Recherche Médicale, France7 sites in 1 country10 target enrollmentNovember 27, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Enrollment
10
Locations
7
Primary Endpoint
PDQ-39 Quality of life questionnary
Status
Completed
Last Updated
11 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 27, 2017
End Date
February 6, 2020
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • contra-indication to neurosurgery

Outcomes

Primary Outcomes

PDQ-39 Quality of life questionnary

Time Frame: Quality of life one year after surgery

PDQ-39 scale

Study Sites (7)

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