Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility (SCP-Comodig)
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Deep brain stimulation
Sponsored by
About this trial
This is an interventional basic science trial for Parkinson's Disease focused on measuring Parkinson's disease, deep brain stimulation, GI motility
Eligibility Criteria
Inclusion Criteria:
- patient over 18 yo
- patient with Parkinson's disease implanted for deep brain stimulation
- patient responders to deep brain stimulation (UPDRS improved by at least 40%)
- patient covered by the french health care system
- patient not taking anti-parkinsonian medication the day before evaluation
- French speaking
Exclusion Criteria:
- patient below 18 yo
- pregnancy
- Severe psychiatric or cognitive disorders
- diabetes mellitus
- morbid obesity
- compulsive eating disorders
- diffuse GI motility impairment (except Parkinson's disease)
- other evolutive neurologic disorders
- previous history of significant GI resection
- inability to swallow or defecate when asked
Sites / Locations
- Rouen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
ON
OFF
Arm Description
Stimulator switched ON
Stimulator switched OFF
Outcomes
Primary Outcome Measures
Anal pressure
Secondary Outcome Measures
Full Information
NCT ID
NCT01081457
First Posted
March 4, 2010
Last Updated
February 6, 2012
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT01081457
Brief Title
Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility
Acronym
SCP-Comodig
Official Title
Effect of Deep Brain Stimulation on Voluntary and Involuntary Gastrointestinal Motility in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Parkinson's disease is characterized by extra-pyramidal symptoms as well as digestive involvement with gastrointestinal motility (GI) impairment. Deep brain stimulation has been recently developed as a successful treatment for extrapyramidal symptoms. In addition, preliminary reports suggest that this therapy might be successful to relieve GI symptoms as well. The aim of this study is therefore to assess the effect of deep brain stimulation on GI voluntary as well as involuntary motility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, deep brain stimulation, GI motility
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ON
Arm Type
Active Comparator
Arm Description
Stimulator switched ON
Arm Title
OFF
Arm Type
Sham Comparator
Arm Description
Stimulator switched OFF
Intervention Type
Device
Intervention Name(s)
Deep brain stimulation
Intervention Description
Comparison ON vs OFF
Primary Outcome Measure Information:
Title
Anal pressure
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patient over 18 yo
patient with Parkinson's disease implanted for deep brain stimulation
patient responders to deep brain stimulation (UPDRS improved by at least 40%)
patient covered by the french health care system
patient not taking anti-parkinsonian medication the day before evaluation
French speaking
Exclusion Criteria:
patient below 18 yo
pregnancy
Severe psychiatric or cognitive disorders
diabetes mellitus
morbid obesity
compulsive eating disorders
diffuse GI motility impairment (except Parkinson's disease)
other evolutive neurologic disorders
previous history of significant GI resection
inability to swallow or defecate when asked
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
ZIP/Postal Code
76031
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
26053217
Citation
Derrey S, Chastan N, Maltete D, Verin E, Dechelotte P, Lefaucheur R, Proust F, Freger P, Leroi AM, Weber J, Gourcerol G. Impact of deep brain stimulation on pharyngo-esophageal motility: a randomized cross-over study. Neurogastroenterol Motil. 2015 Sep;27(9):1214-22. doi: 10.1111/nmo.12607. Epub 2015 Jun 5.
Results Reference
derived
Learn more about this trial
Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility
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