Repetitive Transcranial Magnetic Stimulation in Irritable Bowel Syndrome

University Hospital, Rouen

Status and phase

Completed

Phase 2

Conditions

Irritable Bowel Syndrome

Treatments

Procedure: rTMS

Study type

Interventional

Funder types

Other

Identifiers

NCT01801605

2007-A00799-44

2007/053/HP

Details and patient eligibility

About

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.

Full description

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.

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.