Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation - Full Text View

Sponsored by:	University Hospital, Bordeaux
Information provided by:	University Hospital, Bordeaux
ClinicalTrials.gov Identifier:	NCT00221793

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

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Parkinson disease

MedlinePlus related topics: Parkinson's Disease

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus

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
1: Experimental Deep Brain Stimulation of the Subthalamic Nucleus	Procedure: Deep brain stimulation Brain Stimulation of the Subthalamic Nucleus
2: Active Comparator 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

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:	University Hospital, Bordeaux ( Jean-Pierre LEROY / Clinical Research and Innovation Director )
Study ID Numbers:	9212-02
Study First Received:	September 13, 2005
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00221793 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Bordeaux:

Parkinson
deep subthalamic stimulation
pharmacological treatment

Study placed in the following topic categories:

Body Weight
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases

Body Weight Changes
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:

Movement Disorders
Parkinson Disease
Nervous System Diseases
Basal Ganglia Diseases

Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

ClinicalTrials.gov processed this record on May 06, 2009