Investigation of Cortico-Rectal Pathways in Healthy Subjects and Constipated Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Describe latencies and amplitudes between the brain and gut in healthy volunteers
研究概览
简要总结
Biofeedback therapy improves bowel symptoms and anorectal function in patients with dyssynergic defecation, however its mechanism of action is not known. The investigators hypothesize that biofeedback therapy enhances gut-brain-gut communication by altering cortical processing of information and improving cortically mediated neuromuscular function of the gut. However, in order to better understand these mechanisms in patients, the investigators need to examine and establish normative data and compare findings with healthy subjects. The investigators specific aims are to examine and evaluate the following 40 normal subjects; (1) To evaluate the afferent cortical evoked potentials in response to the electrical stimulation of the anorectum and (2) To evaluate the corticofugal tracts (efferent) by recording the anal and rectal electromyographic responses following noninvasive lumbosacral and transcranial magnetic stimulation.
详细描述
- Cortical evoked potentials:A probe with 2 ring electrodes is placed in anus and rectum. A small amount of electrical current is passed. The cortical evoked responses to the anal and rectal electrical stimulation is measured from the scalp using a neurophysiology recorder.
- Motor evoked potentials: A magnetic coil is placed on the scalp at the anorectal cortical site and discharged using magnetic energy. The anal and rectal motor evoked potentials are then measured using a probe with 2 ring electrodes.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Potential subjects with comorbid illnesses; severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy.
- •Neurologic diseases e.g.; head injury, epilepsy, multiple sclerosis, strokes, spinal cord injuries.
- •People who have metal in their skull or under the skull, or have metal in the back or hips.
- •People who have a cardiac pacemaker, implanted defibrillator or medication pump.
- •Impaired cognizance (mini mental score of < 15) and/or legally blind.
- •Pregnant or likely to conceive during the course of the study. Women with potential for pregnancy must be willing to use contraceptive measures during the study.
- •Previous pelvic surgery, rectocele repair, bladder repair, radical hysterectomy.
- •Rectal prolapse or anal fissure or anal surgery.
结局指标
主要结局
Describe latencies and amplitudes between the brain and gut in healthy volunteers
时间窗: 1 visit of 3 hours
Measurements \& Analysis: The latency, inter-peak latency and amplitude of each component of the cortical evoked potentials will be averaged to obtain group mean data. Statistical Analysis: The paired t-test or Wilcoxon signed-rank test will be used to compare the latencies. Lumbosacral and Transcranial Magnetic Stimulation (TMS) Data and Statistical Analysis: Mean latency and mean amplitude for each individual will be calculated.
次要结局
未报告次要终点