Clinical trial NCT01801605: Repetitive Transcranial Magnetic Stimulation in Irritable Bowel Syndrome
Official title: Does Repetitive Transcranial Magnetic Stimulation (rTMS) Reduce Rectal Hypersensitivity in Patients With IBS ?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: IBS - rectal hypersensitivity - rectal barostat - rTMS.
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2013-03-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Pain or discomfort threshold volumes
timeFrame: final (up to 5 days)
Secondary outcomes:
measure: Amplitude of R3 reflex
measure: Visual analogic scale
measure: Symptoms diary
measure: Quality of life scores
Other outcomes:
Locations:
city: Rouen
country: France
facility: Physiology Unit-Rouen university Hospital
Study officials:
affiliation: CHU Rouen
name: Anne-Marie Leroi, phD
role: PRINCIPAL_INVESTIGATOR
References: