Body Weight Gain, Parkinson, Subthalamic Stimulation

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

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-03

Study Completion Date

2018-06-01

Brief Summary

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Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in patients with motor complications. However, the post-operative body weight gain involved may limit the benefits of surgery and induce critical metabolic disorder. The aim of this study to determine the energy expenditure in usual conditions of life.

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Detailed Description

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Patients will be studied before (between 3 and 1 months) and after (1 month) STN-DBS surgery. Each time the same measurements will be taken. The principal ones will be :

* Clinical examination
* Autoevaluation dietary questionnaire
* Biological tests
* Study in calorimetry chamber (only in Clermont-Ferrand centre)
* Heart rate recorded during 7 days in usual conditions of life
* Energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D)
* Acute Ldopa challenge (in both conditions of dopa and stim)
* Apathy evaluation
* Body weight, and body compositions measurements

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Energy metabolism by chronic bilateral subthalamic stimulation

Patients will be studied before and after STN-DBS surgery

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Aged between 18 and 70 years old
* Diagnosis of Parkinson' disease established for 5 years at least
* Ldopa effect \> 50 %
* Hoehn and Yarh score \> 2.5 in On phase