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

Intervention / Treatment

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)

34

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

No

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

September 13, 2007

First Posted (Estimate)

September 14, 2007

Study Record Updates

Last Update Posted (Actual)

May 24, 2023

Last Update Submitted That Met QC Criteria

May 22, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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