Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus

Conditions
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Parkinson Disease

Intervention / Treatment
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* Procedure: Deep brain stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Deep Brain Stimulation of the Subthalamic Nucleus | Procedure: Deep brain stimulation<br>* Brain Stimulation of the Subthalamic Nucleus<br>|
| Active Comparator: 2<br>Later Deep Brain Stimulation of the Subthalamic Nucleus | Procedure: Deep brain stimulation<br>* Brain Stimulation of the Subthalamic Nucleus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson, deep subthalamic stimulation, pharmacological treatment