Biofeedback and Cortical Excitability (Biofeedback)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00653887|
Recruitment Status : Terminated (Procedure needs to be changed)
First Posted : April 7, 2008
Last Update Posted : February 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Incontinence Constipation||Other: Biofeedback Other: Placebo||Not Applicable|
Introduction: Nervous control of pelvic floor is not much known. The dysfunction of this musculature, and particularly of the external anal sphincter, is a frequent cause of anal incontinence and/or dyschesia. Biofeedback training is often offered to patients suffering from incontinence or constipation. However, its mechanisms of action is still controversial.
Objective of the study: to compare excitability of the cortical area responsible for control volunteer of the external anal sphincter in healthy subjects before and after 4 biofeedback sessions.
Subjects and methodology: we offer to perform two groups of 12 healthy subjects (one active and one control group) without any neurological or digestive disease and having never performed biofeedback. In each group, cortical excitability will be evaluated by cortical magnetic stimulation (curve intensity/amplitude, silent period, inter-stimulus period, motor threshold) before and after 4 biofeedback sessions (one session by week) in active group or 4 placebo sessions (placebo group).
We hope to show a modification of cortical excitability in subjects performing biofeedback compared to others.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Care Provider)|
|Official Title:||Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||December 2009|
Active Comparator: A
biofeedback (active group)
4 sessions of biofeedback one session each week
Placebo Comparator: B
discussion about digestive tract (placebo group)
4 sessions, one each week, of discussion about anorectal disease
- external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction [ Time Frame: final ]
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): NCT00653887
|Physiology Unit - Rouen university Hospital|
|Rouen, France, 76031|
|Principal Investigator:||Anne-Marie LEROI, PhD||CHU Rouen|