Parkinson Disease
Conditions
Keywords
Parkinson, deep subthalamic stimulation, pharmacological treatment
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.
Interventions
PROCEDUREDeep brain stimulation
Brain Stimulation of the Subthalamic Nucleus
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | After surgery and at 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Weight gain | At visit 1 and at 3 months |
| increase of energy intake | At visit 1 and at 3 months |
| leptin, glucose, insulin blood levels | At visite 1 and at 3 months |
| cognitive and psychological assessments | before surgery and after 3 months |
| UDPRS scale | before surgery and after 3 months |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFrançois TISON, Pr
Service de neurologie Hôpital Haut-Lévêque Pessac
STUDY_CHAIRJacques DEMOTES-MAINARD, Pr
CIC Inserm-CHU de Bordeaux Pessac
Outcome results
None listed