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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


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
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