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Body Weight Gain, Parkinson, Subthalamic Stimulation

Primary Purpose

Parkinson's Disease

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Energy metabolism by chronic bilateral subthalamic stimulation
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parkinson's Disease focused on measuring Energy metabolism, metabolic syndrome, by chronic bilateral subthalamic stimulation, Parkinson's disease, Patients with Parkinson's disease and will be treated by chronic bilateral subthalamic stimulation.

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
September 13, 2007
Last Updated
May 22, 2023
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT00529724
Brief Title
Body Weight Gain, Parkinson, Subthalamic Stimulation
Official Title
Mechanisms of Body Weight Gain in Patients With Parkinson's Disease After Subthalamic Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 3, 2007 (Actual)
Primary Completion Date
September 21, 2015 (Actual)
Study Completion Date
June 1, 2018 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Energy metabolism, metabolic syndrome, by chronic bilateral subthalamic stimulation, Parkinson's disease, Patients with Parkinson's disease and will be treated by chronic bilateral subthalamic stimulation.

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Energy metabolism by chronic bilateral subthalamic stimulation
Intervention Description
Patients will be studied before and after STN-DBS surgery
Primary Outcome Measure Information:
Title
heart rate recorded during 7 days in usual conditions of life
Time Frame
7 days in usual conditions of life
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck Durif, Pr
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France

12. IPD Sharing Statement

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Body Weight Gain, Parkinson, Subthalamic Stimulation

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