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
  Purpose

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


Condition Intervention
Incontinence
Constipation
Other: Biofeedback
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Official Title: Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training

Resource links provided by NLM:


Further study details as provided by University Hospital, Rouen:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 24
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653887

Locations
France
Physiology Unit - Rouen university Hospital
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Coloplast A/S
Investigators
Principal Investigator: Anne-Marie LEROI, PhD CHU Rouen
  More Information

No publications provided

Responsible Party: Leroi, Physiology unit
ClinicalTrials.gov Identifier: NCT00653887     History of Changes
Other Study ID Numbers: 2007/054/HP, 2007- A00652-51
Study First Received: April 2, 2008
Last Updated: February 14, 2012
Health Authority: France: Direction Générale de la Santé

Keywords provided by University Hospital, Rouen:
Biofeedback
anal sphincter
cortical excitability
magnetic stimulation
incontinence
constipation

Additional relevant MeSH terms:
Constipation
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 29, 2014