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
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Body Weight
• Parkinson Disease
• Parkinson's Disease
• Weight Gain

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