Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation
Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started Dec 2002
Longer than P75 for not_applicable parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedMay 14, 2026
September 1, 2008
4 years
September 13, 2005
May 11, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
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
Study Arms (2)
1
EXPERIMENTALDeep Brain Stimulation of the Subthalamic Nucleus
2
ACTIVE COMPARATORLater Deep Brain Stimulation of the Subthalamic Nucleus
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- diabetes thyroid disease pacemaker coagulation troubles previous drug abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service de neurologie Hôpital Haut-Lévêque
Pessac, 33604, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François TISON, Pr
Service de neurologie Hôpital Haut-Lévêque Pessac
- STUDY CHAIR
Jacques DEMOTES-MAINARD, Pr
CIC Inserm-CHU de Bordeaux Pessac
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 22, 2005
Study Start
December 1, 2002
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
May 14, 2026
Record last verified: 2008-09