Biofeedback and Cortical Excitability

Not Applicable

Terminated

• Conditions: Incontinence; Constipation
• Interventions: Other: Biofeedback; Other: Placebo

• Registration Number: NCT00653887
• Lead Sponsor: University Hospital, Rouen

Brief 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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-04-02
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-07
• Primary Completion: 2009-09
• Study Completion: 2009-12
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-14
• Last Update Posted: 2012-02-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Biofeedback	biofeedback (active group)
B	Placebo	discussion about digestive tract (placebo group)

Primary Outcome Measures

Name	Time	Method
external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction	final

Trial Locations

Locations (1)

Physiology Unit - Rouen university Hospital; 🇫🇷 Rouen, France