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| Sponsored by: |
University Hospital, Rouen |
| Information provided by: | University Hospital, Rouen |
| ClinicalTrials.gov Identifier: | NCT00639275 |
Purpose
Patients with Parkinson's disease (PD) frequently experience upper gastrointestinal disorders. During the disease, weight loss is often noticed. Recently, many studies have demonstrated that STN-DBS improved extrapyramidal symptoms. Interestingly, PD patients gain weight after STN-DBS, at least in part due to a decrease in resting energy expenditure.
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.
| Condition |
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Parkinson's Disease |
| Genetics Home Reference related topics: | Parkinson disease |
| MedlinePlus related topics: | Parkinson's Disease |
| Study Type: | Observational |
| Study Design: | Other, Prospective |
| Official Title: | Effects of Subthalamic Nucleus Deep Brain Stimulation on Gastrointestinal Symptoms and Motility in Parkinson's Disease. |
Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Parkinson's disease patients with subthalamic nucleus deep brain stimulation
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Nathalie Chastan, MD | 02 32 88 80 37 ext 00 33 | nathalie.chastan@chu-rouen.fr |
| France | |||||
| Rouen University Hospital | Not yet recruiting | ||||
| Rouen, France, 76031 | |||||
| Contact: Nathalie Chastan, MD 02 32 88 80 37 ext 00 33 nathalie.chastan@chu-rouen.fr | |||||
| Principal Investigator: Nathalie Chastan, MD | |||||
| University Hospital, Rouen |
More Information
| Responsible Party: | Direction de la recherche clinique et de l'innovation ( Direction de la recherche clinique et de l'innovation ) |
| Study ID Numbers: | 2007/050/HP |
| First Received: | March 13, 2008 |
| Last Updated: | March 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00639275 |
| Health Authority: | France: Direction Générale de la Santé |
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