Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Procedure: Deep brain stimulation

• Registration Number: NCT00221793
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2002-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-22
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2008-09
• Last Update Submitted: 2008-09-17
• Last Update Posted: 2008-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Deep brain stimulation	Deep Brain Stimulation of the Subthalamic Nucleus
2	Deep brain stimulation	Later Deep Brain Stimulation of the Subthalamic Nucleus

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
increase of energy intake	At visit 1 and at 3 months
UDPRS scale	before surgery and after 3 months
Weight gain	At visit 1 and at 3 months
cognitive and psychological assessments	before surgery and after 3 months
leptin, glucose, insulin blood levels	At visite 1 and at 3 months

Trial Locations

Locations (1)

Service de neurologie Hôpital Haut-Lévêque; 🇫🇷 Pessac, France