Biofeedback and Cortical Excitability

University Hospital, Rouen

Status: Terminated

Conditions: Constipation; Incontinence

Treatments: Other: Placebo; Other: Biofeedback

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00653887

2007/054/HP

2007- A00652-51

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

24 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Description:

biofeedback (active group)

Treatment:

Other: Biofeedback

B

Placebo Comparator group

Description:

discussion about digestive tract (placebo group)

Treatment:

Other: Placebo