Body Weight Gain, Parkinson, Subthalamic Stimulation

May 22, 2023 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Completed

Conditions

Parkinson's Disease

Intervention / Treatment

Behavioral: Energy metabolism by chronic bilateral subthalamic stimulation

Detailed 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

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Clermont-Ferrand, France, 63003
    - CHU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
heart rate recorded during 7 days in usual conditions of life Time Frame: 7 days in usual conditions of life	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) Time Frame: 14 days in usual conditions of life	14 days in usual conditions of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

Principal Investigator: Franck Durif, Pr

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2007

Primary Completion (Actual)

September 21, 2015

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

September 13, 2007

First Submitted That Met QC Criteria