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Biofeedback and Cortical Excitability (Biofeedback)

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ClinicalTrials.gov Identifier: NCT00653887
Recruitment Status : Terminated (Procedure needs to be changed)
First Posted : April 7, 2008
Last Update Posted : February 16, 2012
Sponsor:
Collaborator:
Coloplast A/S
Information provided by:
University Hospital, Rouen

Study Description
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Brief Summary:
Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions.

Condition or disease Intervention/treatment Phase
Incontinence Constipation Other: Biofeedback Other: Placebo Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Official Title: Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training
Study Start Date : January 2008
Actual Primary Completion Date : September 2009
Actual Study Completion Date : December 2009
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A
biofeedback (active group)
 Other: Biofeedback
4 sessions of biofeedback one session each week
Placebo Comparator: B
discussion about digestive tract (placebo group)
 Other: Placebo
4 sessions, one each week, of discussion about anorectal disease


Outcome Measures
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Primary Outcome Measures :
  1. external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction [ Time Frame: final ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Epilepsy
  • Digestive disease
  • Traumatic delivery
  • Anorectal surgery
  • Biofeedback
  • Psychiatric disease
  • Treatment anti-epileptic, hypnotic, psychotropic
  • Participation to a previous protocol within 1 month
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653887


Locations
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France
Physiology Unit - Rouen university Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Coloplast A/S
Investigators
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Principal Investigator: Anne-Marie LEROI, PhD CHU Rouen
More Information
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Responsible Party: Leroi, Physiology unit
ClinicalTrials.gov Identifier: NCT00653887    
Other Study ID Numbers: 2007/054/HP
2007- A00652-51
First Posted: April 7, 2008    Key Record Dates
Last Update Posted: February 16, 2012
Last Verified: February 2012
Keywords provided by University Hospital, Rouen:
Biofeedback
anal sphincter
cortical excitability
 magnetic stimulation
incontinence
constipation
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive