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

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ClinicalTrials.gov Identifier: NCT03128567
Recruitment Status : Unknown
Verified November 2016 by Institut National de la Santé Et de la Recherche Médicale, France.
Recruitment status was:  Not yet recruiting
First Posted : April 25, 2017
Last Update Posted : June 2, 2017
Sponsor:
Information provided by (Responsible Party):
Institut National de la Santé Et de la Recherche Médicale, France

Study Description
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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.

Condition or disease Intervention/treatment
Parkinson Disease Device: Stimulation of the subthalamic nucleus

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 Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Effets de la Stimulation cérébrale Profonde Chez Les Patients âgés Avec Maladie de Parkinson : Essai contrôlé randomisé Multicentrique
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life [ Time Frame: Quality of life one year after surgery ]
    PDQ-39 scale


Eligibility Criteria
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Ages Eligible for Study:   69 Years to 75 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Parkinson's disease
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:

  • dementia
  • contra-indication to neurosurgery
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

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Responsible Party: Institut National de la Santé Et de la Recherche Médicale, France
ClinicalTrials.gov Identifier: NCT03128567    
Other Study ID Numbers: C 14-01
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: June 2, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases