Constipation Clinical Trial
— BiofeedbackOfficial title:
Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training
Verified date | February 2012 |
Source | University Hospital, Rouen |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Direction Générale de la Santé |
Study type | Interventional |
Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions.
Status | Terminated |
Enrollment | 24 |
Est. completion date | December 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver)
Country | Name | City | State |
---|---|---|---|
France | Physiology Unit - Rouen university Hospital | Rouen |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Rouen | Coloplast A/S |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction | final | No |
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