Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility (SCP-Comodig)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Guillaume GOURCEROL, University Hospital, Rouen

ClinicalTrials.gov Identifier:

NCT01081457

First received: March 4, 2010

Last updated: February 6, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 4, 2010
Last Updated Date	February 6, 2012
Start Date ^ICMJE	January 2010
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 4, 2010)	Anal pressure [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01081457 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of Deep Brain Stimulation on Gastrointestinal (GI) Motility
Official Title ^ICMJE	Effect of Deep Brain Stimulation on Voluntary and Involuntary Gastrointestinal Motility in Parkinson's Disease
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Parkinson's Disease
Intervention ^ICMJE	Device: Deep brain stimulation Comparison ON vs OFF
Study Arm (s)	Active Comparator: ON Stimulator switched ON Intervention: Device: Deep brain stimulation Sham Comparator: OFF Stimulator switched OFF Intervention: Device: Deep brain stimulation
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	16
Completion Date	January 2012
Primary Completion Date	January 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	France

Administrative Information
NCT Number ^ICMJE	NCT01081457
Other Study ID Numbers ^ICMJE	2008/163/HP
Has Data Monitoring Committee	Yes
Responsible Party	Guillaume GOURCEROL, University Hospital, Rouen
Study Sponsor ^ICMJE	University Hospital, Rouen
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University Hospital, Rouen
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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