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Deep Brain Stimulation and Digestive Symptomatology (SCPDig)

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ClinicalTrials.gov Identifier: NCT00639275
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : January 10, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Study Description
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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.


Condition or disease
Parkinson's Disease

Study Design
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Study Type : Observational
Actual Enrollment : 14 participants
Time Perspective: Prospective
Official Title: Effects of Subthalamic Nucleus Deep Brain Stimulation on Gastrointestinal Symptoms and Motility in Parkinson's Disease.
Study Start Date : June 2008
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

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Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. the gastric emptying measurement with the 13C-octanoic acid breath test [ Time Frame: M0 and M6 ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639275


Locations
France
Rouen University Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT00639275     History of Changes
Other Study ID Numbers: 2007/050/HP
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: January 2013

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