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Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Deep brain stimulation
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parkinson Disease focused on measuring Parkinson, deep subthalamic stimulation, pharmacological treatment

Eligibility Criteria

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

Inclusion Criteria: Age between 35 and 70; male or female; parkinson disease, with levo dopa response (at least 30%); severe but stable incapacity; no dementia, no psychosis, no depression; normal brain scanner done during the last 2 years. Exclusion Criteria: diabetes thyroid disease pacemaker coagulation troubles previous drug abuse

Sites / Locations

  • Service de neurologie Hôpital Haut-Lévêque

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Deep Brain Stimulation of the Subthalamic Nucleus

Later Deep Brain Stimulation of the Subthalamic Nucleus

Outcomes

Primary Outcome Measures

Measurement of energy expenditure with indirect calorimetry in open chamber: at rest in the morning, without 24h-dopaminergic treatment, and after dopaminergic treatment intake; and post prandial thermogenesis after a test meal.

Secondary Outcome Measures

Weight gain
increase of energy intake
leptin, glucose, insulin blood levels
cognitive and psychological assessments
UDPRS scale

Full Information

First Posted
September 13, 2005
Last Updated
September 17, 2008
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT00221793
Brief Title
Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation
Official Title
Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and to study its link with an energetic balance change.
Detailed Description
The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and to study its link with an energetic balance change. Twenty parkinsonian patients will be randomised : the delay between inclusion and neurostimulation wil be lengthened 3 months for one group, compared to the second one. The energy expenditure, at rest and after ingestion of a test meal, will be compared between the group of patients that had been neurostimulated and the group whose intervention has been postponed. Weight changes, energy intake, leptin level, neurophysiological parameters will be compared between both groups, and the nature and repartition of the weight gain will be assessed in the neurostimulated group. An eventual link between motor factors, pharmacological factors, and gain weight will be studied.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson, deep subthalamic stimulation, pharmacological treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Deep Brain Stimulation of the Subthalamic Nucleus
Arm Title
2
Arm Type
Active Comparator
Arm Description
Later Deep Brain Stimulation of the Subthalamic Nucleus
Intervention Type
Procedure
Intervention Name(s)
Deep brain stimulation
Intervention Description
Brain Stimulation of the Subthalamic Nucleus
Primary Outcome Measure Information:
Title
Measurement of energy expenditure with indirect calorimetry in open chamber: at rest in the morning, without 24h-dopaminergic treatment, and after dopaminergic treatment intake; and post prandial thermogenesis after a test meal.
Time Frame
After surgery and at 3 months
Secondary Outcome Measure Information:
Title
Weight gain
Time Frame
At visit 1 and at 3 months
Title
increase of energy intake
Time Frame
At visit 1 and at 3 months
Title
leptin, glucose, insulin blood levels
Time Frame
At visite 1 and at 3 months
Title
cognitive and psychological assessments
Time Frame
before surgery and after 3 months
Title
UDPRS scale
Time Frame
before surgery and after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age between 35 and 70; male or female; parkinson disease, with levo dopa response (at least 30%); severe but stable incapacity; no dementia, no psychosis, no depression; normal brain scanner done during the last 2 years. Exclusion Criteria: diabetes thyroid disease pacemaker coagulation troubles previous drug abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François TISON, Pr
Organizational Affiliation
Service de neurologie Hôpital Haut-Lévêque Pessac
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacques DEMOTES-MAINARD, Pr
Organizational Affiliation
CIC Inserm-CHU de Bordeaux Pessac
Official's Role
Study Chair
Facility Information:
Facility Name
Service de neurologie Hôpital Haut-Lévêque
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

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Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation

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