Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation
This study has been completed.
Sponsor:
University Hospital, Bordeaux
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00221793
First received: September 13, 2005
Last updated: September 17, 2008
Last verified: September 2008
| Tracking Information | |||||||||
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| First Received Date ICMJE | September 13, 2005 | ||||||||
| Last Updated Date | September 17, 2008 | ||||||||
| Start Date ICMJE | December 2002 | ||||||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE |
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. | ||||||||
| Change History | Complete list of historical versions of study NCT00221793 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Weight gain, increase of energy intake; leptin, glucose, insulin blood levels ; cognitive and psychological assessments ; UDPRS scale | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Weight Changes in Parkinsonian Patients, Treated With Deep Brain Stimulation | ||||||||
| Official Title ICMJE | Study of Ponderal Load in Parkinsonian Patients After Deep Brain Stimulation of the Subthalamic Nucleus | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Parkinson Disease | ||||||||
| Intervention ICMJE | Procedure: Deep brain stimulation
Brain Stimulation of the Subthalamic Nucleus |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 20 | ||||||||
| Completion Date | December 2006 | ||||||||
| Primary Completion Date | December 2006 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 35 Years to 70 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00221793 | ||||||||
| Other Study ID Numbers ICMJE | 9212-02 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux | ||||||||
| Study Sponsor ICMJE | University Hospital, Bordeaux | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Bordeaux | ||||||||
| Verification Date | September 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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