Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221793
First received: September 13, 2005
Last updated: September 17, 2008
Last verified: September 2008

September 13, 2005
September 17, 2008
December 2002
December 2006   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00221793 on ClinicalTrials.gov Archive Site
  • Weight gain [ Time Frame: At visit 1 and at 3 months ] [ Designated as safety issue: No ]
  • increase of energy intake [ Time Frame: At visit 1 and at 3 months ] [ Designated as safety issue: No ]
  • leptin, glucose, insulin blood levels [ Time Frame: At visite 1 and at 3 months ] [ Designated as safety issue: No ]
  • cognitive and psychological assessments [ Time Frame: before surgery and after 3 months ] [ Designated as safety issue: No ]
  • UDPRS scale [ Time Frame: before surgery and after 3 months ] [ Designated as safety issue: No ]
Weight gain, increase of energy intake; leptin, glucose, insulin blood levels ; cognitive and psychological assessments ; UDPRS scale
Not Provided
Not Provided
 
Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation
Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus

The aim of this trial is to verify that neurostimulated parkinsonian patients gain weight and to study its link with an energetic balance change.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Parkinson Disease
Procedure: Deep brain stimulation
Brain Stimulation of the Subthalamic Nucleus
  • Experimental: 1
    Deep Brain Stimulation of the Subthalamic Nucleus
    Intervention: Procedure: Deep brain stimulation
  • Active Comparator: 2
    Later Deep Brain Stimulation of the Subthalamic Nucleus
    Intervention: Procedure: Deep brain stimulation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2006
December 2006   (final data collection date for primary outcome measure)

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
Both
35 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00221793
9212-02
No
Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Principal Investigator: François TISON, Pr Service de neurologie Hôpital Haut-Lévêque Pessac
Study Chair: Jacques DEMOTES-MAINARD, Pr CIC Inserm-CHU de Bordeaux Pessac
University Hospital, Bordeaux
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP