Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility
SCP-Comodig
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2010
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 4, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedFebruary 7, 2012
February 1, 2012
2 years
March 4, 2010
February 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Anal pressure
2 hours
Study Arms (2)
ON
ACTIVE COMPARATORStimulator switched ON
OFF
SHAM COMPARATORStimulator switched OFF
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rouen University Hospital
Rouen, 76031, France
Related Publications (1)
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.
PMID: 26053217DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
March 4, 2010
First Posted
March 5, 2010
Study Start
January 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
February 7, 2012
Record last verified: 2012-02