Biofeedback and Cortical Excitability

Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00653887

Acronym

Biofeedback

Enrollment

Registered

2008-04-07

Start date

2008-01-31

Completion date

2009-12-31

Last updated

2012-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Constipation, Incontinence

Keywords

Biofeedback, anal sphincter, cortical excitability, magnetic stimulation, incontinence, constipation

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.

Interventions

OTHERBiofeedback

4 sessions of biofeedback one session each week

OTHERPlacebo

4 sessions, one each week, of discussion about anorectal disease

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

18 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026