Deep Brain Stimulation for Patients With Parkinson's Disease.

NCT ID: NCT03128567

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-27

Study Completion Date

2020-02-06

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Stimulation of the subthalamic nucleus

25 patients with Parkinson's disease

Stimulation of the subthalamic nucleus

Intervention Type DEVICE

Stimulation of the subthalamic nucleus

Best medical treatment

25 patients with Parkinson's disease

No interventions assigned to this group

Interventions

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Stimulation of the subthalamic nucleus

Stimulation of the subthalamic nucleus

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

69 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Service d'EFSN, Hôpital Pellegrin

Bordeaux, , France

Site Status

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

Lille, , France

Site Status

Hôpital Neurologique Pierre Wertheimer, Service de Neurologie

Lyon, , France

Site Status

Département des maladies du Système Nerveux, Hôpital Pitié-Salpétrière

Paris, , France

Site Status

Service de Neurologie, Pôle Neurosciences, CHU de Poitiers

Poitiers, , France

Site Status

CHU Charles Nicolle

Rouen, , France

Site Status

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

Toulouse, , France

Site Status

Countries

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France

Other Identifiers

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C 14-01

Identifier Type: -

Identifier Source: org_study_id

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