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Biofeedback and Cortical Excitability (Biofeedback)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00653887
Recruitment Status : Terminated (Procedure needs to be changed)
First Posted : April 7, 2008
Last Update Posted : February 16, 2012
Coloplast A/S
Information provided by:
University Hospital, Rouen

Tracking Information
First Submitted Date  ICMJE April 2, 2008
First Posted Date  ICMJE April 7, 2008
Last Update Posted Date February 16, 2012
Study Start Date  ICMJE January 2008
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2008)
external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction [ Time Frame: final ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Biofeedback and Cortical Excitability
Official Title  ICMJE Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Condition  ICMJE
  • Incontinence
  • Constipation
Intervention  ICMJE
  • Other: Biofeedback
    4 sessions of biofeedback one session each week
  • Other: Placebo
    4 sessions, one each week, of discussion about anorectal disease
Study Arms  ICMJE
  • Active Comparator: A
    biofeedback (active group)
    Intervention: Other: Biofeedback
  • Placebo Comparator: B
    discussion about digestive tract (placebo group)
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: April 4, 2008)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date September 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00653887
Other Study ID Numbers  ICMJE 2007/054/HP
2007- A00652-51
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Leroi, Physiology unit
Study Sponsor  ICMJE University Hospital, Rouen
Collaborators  ICMJE Coloplast A/S
Investigators  ICMJE
Principal Investigator: Anne-Marie LEROI, PhD CHU Rouen
PRS Account University Hospital, Rouen
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP