Does Repetitive Transcranial Magnetic Stimulation (rTMS) Reduce Rectal Hypersensitivity in Patients With IBS ?
rTMS
+ rTMS
Colonic Diseases+3
+ Colonic Diseases, Functional
+ Digestive System Diseases
Summary
Study start date: August 1, 2008
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.20 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Physiology Unit-Rouen university Hospital
Rouen, FranceOpen Physiology Unit-Rouen university Hospital in Google Maps