Deep Brain Stimulation and Digestive Symptomatology

Completed

• Conditions: Parkinson's Disease

• Registration Number: NCT00639275
• Lead Sponsor: University Hospital, Rouen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-13
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-20
• Study Start: 2008-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-08
• Last Update Posted: 2013-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the gastric emptying measurement with the 13C-octanoic acid breath test	M0 and M6

Trial Locations

Locations (1)

Rouen University Hospital; 🇫🇷 Rouen, France