Trials / Completed
CompletedNCT00639275
Deep Brain Stimulation and Digestive Symptomatology
Effects of Subthalamic Nucleus Deep Brain Stimulation on Gastrointestinal Symptoms and Motility in Parkinson's Disease.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 14 (actual)
- Sponsor
- University Hospital, Rouen · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2012-06-01
- Completion
- 2012-06-01
- First posted
- 2008-03-20
- Last updated
- 2013-01-10
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT00639275. Inclusion in this directory is not an endorsement.