Deep Brain Stimulation and Digestive Symptomatology (SCPDig)
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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 |
|---|
|
Parkinson's Disease |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Effects of Subthalamic Nucleus Deep Brain Stimulation on Gastrointestinal Symptoms and Motility in Parkinson's Disease. |
- the gastric emptying measurement with the 13C-octanoic acid breath test [ Time Frame: M0 and M6 ] [ Designated as safety issue: No ]
| Enrollment: | 14 |
| Study Start Date: | June 2008 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
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:
- 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
- Diabetes
- Obesity
- Compulsive eating disorders
- Organic digestive disease
- Gastrointestinal resection
- Prokinetic treatment
- Coagulopathy
Contacts and Locations
More Information
No publications provided
| Responsible Party: | University Hospital, Rouen |
| ClinicalTrials.gov Identifier: | NCT00639275 History of Changes |
| Other Study ID Numbers: | 2007/050/HP |
| Study First Received: | March 13, 2008 |
| Last Updated: | January 8, 2013 |
| Health Authority: | France: Direction Générale de la Santé |
Additional relevant MeSH terms:
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |
ClinicalTrials.gov processed this record on June 13, 2013