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Clinical Trials/NCT00653887
NCT00653887
Terminated
Not Applicable

Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training

University Hospital, Rouen1 site in 1 country24 target enrollmentJanuary 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Incontinence
Sponsor
University Hospital, Rouen
Enrollment
24
Locations
1
Primary Endpoint
external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction
Status
Terminated
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
December 2009
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Rouen

Eligibility Criteria

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
  • Digestive disease
  • Traumatic delivery
  • Anorectal surgery
  • Biofeedback
  • Psychiatric disease
  • Treatment anti-epileptic, hypnotic, psychotropic
  • Participation to a previous protocol within 1 month

Outcomes

Primary Outcomes

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

Time Frame: final

Study Sites (1)

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