Biofeedback and Cortical Excitability (Biofeedback)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
|Official Title:||Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training|
- external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction [ Time Frame: final ] [ Designated as safety issue: No ]
|Study Start Date:||January 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||September 2009 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00653887
|Physiology Unit - Rouen university Hospital|
|Rouen, France, 76031|
|Principal Investigator:||Anne-Marie LEROI, PhD||CHU Rouen|