Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus |
- 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 ]
- 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 |
|---|---|
|
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
|
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 |
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| France | |
| Service de neurologie Hôpital Haut-Lévêque | |
| Pessac, France, 33604 | |
| 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: | Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT00221793 History of Changes |
| Other Study ID Numbers: | 9212-02 |
| Study First Received: | September 13, 2005 |
| Last Updated: | September 17, 2008 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
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 |
ClinicalTrials.gov processed this record on June 17, 2013