Biofeedback and Cortical Excitability

This study has been terminated.
(Procedure needs to be changed)
Sponsor:
Collaborator:
Coloplast A/S
Information provided by:
University Hospital, Rouen
ClinicalTrials.gov Identifier:
NCT00653887
First received: April 2, 2008
Last updated: February 14, 2012
Last verified: February 2012

April 2, 2008
February 14, 2012
January 2008
September 2009   (final data collection date for primary outcome measure)
external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction [ Time Frame: final ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00653887 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Biofeedback and Cortical Excitability
Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training

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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
  • Incontinence
  • Constipation
  • Other: Biofeedback
    4 sessions of biofeedback one session each week
  • Other: Placebo
    4 sessions, one each week, of discussion about anorectal disease
  • Active Comparator: A
    biofeedback (active group)
    Intervention: Other: Biofeedback
  • Placebo Comparator: B
    discussion about digestive tract (placebo group)
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
24
December 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00653887
2007/054/HP, 2007- A00652-51
Yes
Leroi, Physiology unit
University Hospital, Rouen
Coloplast A/S
Principal Investigator: Anne-Marie LEROI, PhD CHU Rouen
University Hospital, Rouen
February 2012

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