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SCPDig: Deep Brain Stimulation and Digestive Symptomatology

Sponsor
University Hospital, Rouen (Other)
Overall Status
Completed
CT.gov ID
NCT00639275
Collaborator
(none)
14
Enrollment
1
Location
48
Duration (Months)
0.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    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 :
    Jun 1, 2008
    Actual Primary Completion Date :
    Jun 1, 2012
    Actual Study Completion Date :
    Jun 1, 2012

    Outcome Measures

    Primary Outcome Measures

    1. the gastric emptying measurement with the 13C-octanoic acid breath test [M0 and M6]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Rouen University Hospital Rouen France 76031

    Sponsors and Collaborators

    • University Hospital, Rouen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Rouen
    ClinicalTrials.gov Identifier:
    NCT00639275
    Other Study ID Numbers:
    • 2007/050/HP
    First Posted:
    Mar 20, 2008
    Last Update Posted:
    Jan 10, 2013
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Jan 10, 2013