Modifications of the Anal Muscle Cortical Excitability Area After Biofeedback Training
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction
研究概览
简要总结
Looking for a modification of the cortical excitability of the motor area corresponding to the external anal sphincter after biofeedback sessions.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers between 18 years old and 35 years old
- •Right handed*
排除标准
- •Pregnancy
- •Pace-maker or other metallic piece implanted in the body
- •Neurological disease
- •Digestive disease
- •Traumatic delivery
- •Anorectal surgery
- •Biofeedback
- •Psychiatric disease
- •Treatment anti-epileptic, hypnotic, psychotropic
- •Participation to a previous protocol within 1 month
结局指标
主要结局
external anal sphincter motor threshold silent period double-pulse stimulation: inter-stimulus interval amplitude and duration of external anal sphincter contraction
时间窗: final
次要结局
未报告次要终点