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Deep Brain Stimulation and Digestive Symptomatology (SCPDig)
This study is not yet open for participant recruitment.
Study NCT00639275   Information provided by University Hospital, Rouen
First Received: March 13, 2008   Last Updated: March 19, 2008   History of Changes

March 13, 2008
March 19, 2008
April 2008
 
the gastric emptying measurement with the 13C-octanoic acid breath test [ Time Frame: M0 and M6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00639275 on ClinicalTrials.gov Archive Site
 
 
 
Deep Brain Stimulation and Digestive Symptomatology
Effects of Subthalamic Nucleus Deep Brain Stimulation on Gastrointestinal Symptoms and Motility in Parkinson's Disease.

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.

 
 
Observational
Other, Prospective
Parkinson's Disease
 
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
16
 
 

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
Both
18 Years to 70 Years
No
Contact: Nathalie Chastan, MD 02 32 88 80 37 ext 00 33 nathalie.chastan@chu-rouen.fr
France
 
NCT00639275
Direction de la recherche clinique et de l'innovation, Direction de la recherche clinique et de l'innovation
2007/050/HP
University Hospital, Rouen
 
 
University Hospital, Rouen
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP