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NCT00529724 Clinical Trial

Body Weight Gain, Parkinson, Subthalamic Stimulation

Parkinson's Disease Clinical Trial

Official title:
Mechanisms of Body Weight Gain in Patients With Parkinson's Disease After Subthalamic Stimulation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00529724
Other study ID # CHU-0024
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 3, 2007
Est. completion date June 1, 2018

Study information
Verified date May 2023
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 34
Est. completion date June 1, 2018
Est. primary completion date September 21, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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 Exclusion Criteria: - Metabolism disorder - Biological analysis abnormal

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Energy metabolism by chronic bilateral subthalamic stimulation
Patients will be studied before and after STN-DBS surgery

Locations
Country Name City State
France CHU Clermont-Ferrand

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary heart rate recorded during 7 days in usual conditions of life 7 days in usual conditions of life
Primary energy expenditure recorded during 14 days in usual conditions of life with normalized water (18O 10 %) and Deuterium oxide (99.94 %D) 14 days in usual conditions of life
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