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Deep Brain Stimulation and Digestive Symptomatology (SCPDig)

This study is not yet open for participant recruitment.
Verified by University Hospital, Rouen, March 2008

Sponsored by: University Hospital, Rouen
Information provided by: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00639275
  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

Genetics Home Reference related topics:   Parkinson disease   

MedlinePlus related topics:   Parkinson's Disease   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other, Prospective
Official Title:   Effects of Subthalamic Nucleus Deep Brain Stimulation on Gastrointestinal Symptoms and Motility in Parkinson's Disease.

Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • the gastric emptying measurement with the 13C-octanoic acid breath test [ Time Frame: M0 and M6 ] [ Designated as safety issue: No ]

Estimated Enrollment:   16
Study Start Date:   April 2008

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Parkinson's disease patients with subthalamic nucleus deep brain stimulation


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
  • Diabetes
  • Obesity
  • Compulsive eating disorders
  • Organic digestive disease
  • Gastrointestinal resection
  • Prokinetic treatment
  • Coagulopathy
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00639275

Contacts
Contact: Nathalie Chastan, MD     02 32 88 80 37 ext 00 33     nathalie.chastan@chu-rouen.fr    

Locations
France
Rouen University Hospital     Not yet recruiting
      Rouen, France, 76031
      Contact: Nathalie Chastan, MD     02 32 88 80 37 ext 00 33     nathalie.chastan@chu-rouen.fr    
      Principal Investigator: Nathalie Chastan, MD            

Sponsors and Collaborators
University Hospital, Rouen
  More Information

Responsible Party:   Direction de la recherche clinique et de l'innovation ( Direction de la recherche clinique et de l'innovation )
Study ID Numbers:   2007/050/HP
First Received:   March 13, 2008
Last Updated:   March 19, 2008
ClinicalTrials.gov Identifier:   NCT00639275
Health Authority:   France: Direction Générale de la Santé

Study placed in the following topic categories:
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on August 20, 2008




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