Deep Brain Stimulation and Digestive Symptomatology

Parkinson's Disease Clinical Trial

— SCPDig  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00639275
• Other study ID #: 2007/050/HP
• Status: Completed
• Phase: N/A
• First received: March 13, 2008
• Last updated: January 8, 2013
• Start date: June 2008
• Est. completion date: June 2012

Study information

• Verified date: January 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the gastric emptying measurement with the 13C-octanoic acid breath test		M0 and M6	No