Biofeedback and Cortical Excitability

Constipation Clinical Trial

— Biofeedback  

Official title:

Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00653887
• Other study ID #: 2007/054/HP
• Secondary ID: 2007- A00652-51
• Status: Terminated
• Phase: N/A
• First received: April 2, 2008
• Last updated: February 14, 2012
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: February 2012
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver)

Related Conditions & MeSH terms

• Constipation
• Incontinence

Intervention

Other:
• Biofeedback
4 sessions of biofeedback one session each week
• Placebo
4 sessions, one each week, of discussion about anorectal disease

Locations

Country	Name	City	State
France	Physiology Unit - Rouen university Hospital	Rouen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Rouen	Coloplast A/S

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction		final	No