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| ID | Type | Description | Link |
|---|---|---|---|
| 2007- A00652-51 |
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Procedure needs to be changed
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| Name | Class |
|---|---|
| Coloplast A/S | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | biofeedback (active group) |
|
| B | Placebo Comparator | discussion about digestive tract (placebo group) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofeedback | Other | 4 sessions of biofeedback one session each week |
| |
| Measure | Description | Time Frame |
|---|---|---|
| external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction | final |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Marie LEROI, PhD | CHU Rouen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physiology Unit - Rouen university Hospital | Rouen | 76031 | France |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D001521 | Behavior Therapy |
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| Placebo |
| Other |
4 sessions, one each week, of discussion about anorectal disease |
|
| D011613 |
| Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |