Biofeedback and Cortical Excitability

Study Overview
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Brief Summary
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Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions.

Detailed Description
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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.

Official Title
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Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training

Conditions
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Incontinence, Constipation

Intervention / Treatment
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* Other: Biofeedback
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy volunteers between 18 years old and 35 years old Right handed* Exclusion Criteria: Pregnancy Pace-maker or other metallic piece implanted in the body Neurological disease Epilepsy Digestive disease Traumatic delivery Anorectal surgery Biofeedback Psychiatric disease Treatment anti-epileptic, hypnotic, psychotropic Participation to a previous protocol within 1 month

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>biofeedback (active group) | Other: Biofeedback<br>* 4 sessions of biofeedback one session each week<br>|
| Placebo Comparator: B<br>discussion about digestive tract (placebo group) | Other: Placebo<br>* 4 sessions, one each week, of discussion about anorectal disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction |  | final | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biofeedback, anal sphincter, cortical excitability, magnetic stimulation, incontinence, constipation