Study Results
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Basic Information
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COMPLETED
14 participants
OBSERVATIONAL
2008-06-30
2012-06-30
Brief Summary
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Purpose: To evaluate benefits of STN-DBS on upper gastrointestinal symptoms and motility.
Patients et method: PD patients waiting for STN-DBS, will be assessed in a preoperative time (2 times at, at least, 3 month intervals, to evaluate the natural history of the disease on upper gastrointestinal symptoms and motility) and in a postoperative time, after 6 months of chronic STN-DBS. Each assessment will include : 1/ questionnaires about frequency and severity of upper gastrointestinal symptoms; 2/ a nutritional assessment (body mass index, dietary assessment); 3/ the gastric emptying measurement with the 13C-octanoic acid breath test; 4/ the colorectal transit time measurement with radio-opaque markers 5/ an indirect calorimetry to estimate resting energy expenditure; 6/ and plasmatic leptin and ghrelin concentrations, hormones involved in the homeostatic regulation of appetite.
Perspectives: This physiopathological study should allow us to understand the mechanisms of the effects of STN-DBS on upper gastrointestinal symptoms and weight regulation in PD patients.
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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Electrode implantation for deep brain stimulation in progress
* Age \<70 yr
* Motor fluctuations and dyskinesias
* Motor symptoms improvement with L-dopa \> 50%
* No dementia
* No depression
* No major psychiatric symptom
* Normal brain MRI
Exclusion Criteria
* Pregnancy
* Diabetes
* Obesity
* Compulsive eating disorders
* Organic digestive disease
* Gastrointestinal resection
* Prokinetic treatment
* Coagulopathy
18 Years
70 Years
ALL
No
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Locations
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Rouen University Hospital
Rouen, , France
Countries
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Other Identifiers
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2007/050/HP
Identifier Type: -
Identifier Source: org_study_id
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