Does Repetitive Transcranial Magnetic Stimulation (rTMS) Reduce Rectal Hypersensitivity in Patients With IBS ?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain or discomfort threshold volumes
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Repetitive Transcranial Magnetic Stimulation (rTMS) on rectal hypersensitivity in patients with irritable bowel syndrome (IBS) in a prospective, randomized, double-blind study.
详细描述
IBS patients frequently demonstrate a rectal hypersensitivity which could participate to the abdominal pain. rTMS is an effective treatment of neurogenic chronic pain. The aim of the study is to evaluate the efficacy of rTMS on rectal hypersensitivity in patients with IBS in a prospective, randomized, double-blind study.
Patients and method: 20 patients with rectal hypersensitivity secondary to IBS will have one active session of rTMS located on the cortical area of the abdominal muscles during 5 consecutive days and one session of simulated rTMS during 5 over consecutive days corresponding to the placebo session. The order of the two session will be randomized. The efficacy of rTMS will be assessed by a rectal barostat to determine the pain or discomfort threshold and by a RIII reflex. The barostat and RIII reflex will be performed at the beginning and at the end of each session.
The investigators hope to demonstrate an improvement of the rectal hypersensitivity during the active stimulations compared to the placebo one.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •more than 18 years old
- •IBS defined by Rome III criteria
- •Rectal hypersensitivity evaluated by barotat with a pain or inconfort volume less than 28 mmHg
- •IBS for more than 3 months
- •With an organic exploration for less than 6 months
- •Without any knowledge concerning the rTMS
排除标准
- •Pregnant women or women without any contraception
- •Patients with pace-maker or other metallic implant
- •Patients complaining of epilepsia or with past of epilepsia
- •Patients with psychiatric disorders
- •Patients treated by any drugs which could interfere with rTMS
- •Patients having participate to another protocol within the month preceeding the inclusion
- •Patients who could not stop the antalgic drugs within the week preceeding the onset of the study
- •patients with a significant lesion on RMI.
结局指标
主要结局
Pain or discomfort threshold volumes
时间窗: final (up to 5 days)
次要结局
- Amplitude of R3 reflex
- Visual analogic scale
- Symptoms diary
- Quality of life scores