Deep Brain Stimulation and Digestive Symptomatology (SCPDig)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00639275
First received: March 13, 2008
Last updated: January 8, 2013
Last verified: January 2013
  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

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

Resource links provided by NLM:


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 ]

Enrollment: 14
Study Start Date: June 2008
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
  More Information

No publications provided

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00639275     History of Changes
Other Study ID Numbers: 2007/050/HP
Study First Received: March 13, 2008
Last Updated: January 8, 2013
Health Authority: France: Direction Générale de la Santé

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on September 15, 2014