Biofeedback and Cortical Excitability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

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.

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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.

Conditions

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Incontinence Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Caregivers

Study Groups

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A

biofeedback (active group)

Group Type ACTIVE_COMPARATOR

Biofeedback

Intervention Type OTHER

4 sessions of biofeedback one session each week

B

discussion about digestive tract (placebo group)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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Biofeedback

4 sessions of biofeedback one session each week

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes