We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00221793
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 18, 2008
Sponsor:
Information provided by:
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment
Parkinson Disease Procedure: Deep brain stimulation

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus
Study Start Date : December 2002
Primary Completion Date : December 2006
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 Measures :
  1. Weight gain [ Time Frame: At visit 1 and at 3 months ]
  2. increase of energy intake [ Time Frame: At visit 1 and at 3 months ]
  3. leptin, glucose, insulin blood levels [ Time Frame: At visite 1 and at 3 months ]
  4. cognitive and psychological assessments [ Time Frame: before surgery and after 3 months ]
  5. UDPRS scale [ Time Frame: before surgery and after 3 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 18, 2008
Last Verified: September 2008

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