Effects of Subthalamic Nucleus Deep Brain Stimulation on Gastrointestinal Symptoms and Motility in Parkinson's Disease.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- University Hospital, Rouen
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- the gastric emptying measurement with the 13C-octanoic acid breath test
- Status
- Completed
- Last Updated
- 13 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Parkinson's disease
- •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
- •Contra-indication of neurosurgery
- •Pregnancy
- •Compulsive eating disorders
- •Organic digestive disease
- •Gastrointestinal resection
- •Prokinetic treatment
- •Coagulopathy
Outcomes
Primary Outcomes
the gastric emptying measurement with the 13C-octanoic acid breath test
Time Frame: M0 and M6