Skip to main content
Clinical Trials/NCT00639275
NCT00639275
Completed
N/A

Effects of Subthalamic Nucleus Deep Brain Stimulation on Gastrointestinal Symptoms and Motility in Parkinson's Disease.

University Hospital, Rouen1 site in 1 country14 target enrollmentJune 2008

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.

Registry
clinicaltrials.gov
Start Date
June 2008
End Date
June 2012
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Rouen
Responsible Party
Sponsor

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

Study Sites (1)

Loading locations...

Similar Trials