Biofeedback and Cortical Excitability (Biofeedback)

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

Tracking Information

• First Submitted Date: April 2, 2008
• First Posted Date: April 7, 2008
• Last Update Posted Date: February 16, 2012
• Study Start Date: January 2008
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Biofeedback and Cortical Excitability
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Care Provider)

Condition

• Incontinence
• Constipation

Intervention

• Other: Biofeedback
  4 sessions of biofeedback one session each week
• Other: Placebo
  4 sessions, one each week, of discussion about anorectal disease

Study Arms

• Active Comparator: A
  biofeedback (active group)
  Intervention: Other: Biofeedback
• Placebo Comparator: B
  discussion about digestive tract (placebo group)
  Intervention: Other: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Estimated Enrollment (submitted: April 4, 2008): 24
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)

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
• 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

• Sexes Eligible for Study: All

• Ages: 18 Years to 35 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00653887
• Other Study ID Numbers: 2007/054/HP; 2007- A00652-51
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Leroi, Physiology unit
• Study Sponsor: University Hospital, Rouen
• Collaborators: Coloplast A/S

Investigators

• Principal Investigator: Anne-Marie LEROI, PhD; CHU Rouen

• PRS Account: University Hospital, Rouen
• Verification Date: February 2012