Clinical Trials Directory

Trials / Terminated

TerminatedNCT00653887

Biofeedback and Cortical Excitability

Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
24 (estimated)
Sponsor
University Hospital, Rouen · Academic / Other
Sex
All
Age
18 Years – 35 Years
Healthy volunteers
Accepted

Summary

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

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHERBiofeedback4 sessions of biofeedback one session each week
OTHERPlacebo4 sessions, one each week, of discussion about anorectal disease

Timeline

Start date
2008-01-01
Primary completion
2009-09-01
Completion
2009-12-01
First posted
2008-04-07
Last updated
2012-02-16

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT00653887. Inclusion in this directory is not an endorsement.