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
  Purpose

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


Condition Intervention
Parkinson Disease
Procedure: Deep brain stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

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. [ Time Frame: After surgery and at 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: December 2002
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Deep Brain Stimulation of the Subthalamic Nucleus
Procedure: Deep brain stimulation
Brain Stimulation of the Subthalamic Nucleus
Active Comparator: 2
Later Deep Brain Stimulation of the Subthalamic Nucleus
Procedure: Deep brain stimulation
Brain Stimulation of the Subthalamic Nucleus

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.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00221793

Locations
France
Service de neurologie Hôpital Haut-Lévêque
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: François TISON, Pr Service de neurologie Hôpital Haut-Lévêque Pessac
Study Chair: Jacques DEMOTES-MAINARD, Pr CIC Inserm-CHU de Bordeaux Pessac
  More Information

No publications provided

Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00221793     History of Changes
Other Study ID Numbers: 9212-02
Study First Received: September 13, 2005
Last Updated: September 17, 2008
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Parkinson
deep subthalamic stimulation
pharmacological treatment

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on July 22, 2014