Repetitive Transcranial Magnetic Stimulation in Irritable Bowel Syndrome

NCT ID: NCT01801605

Last Updated: 2013-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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on

active session

Group Type ACTIVE_COMPARATOR

rTMS

Intervention Type PROCEDURE

Active session with stimulation and placebo session with fictive stimulation

off

fictive session

Group Type PLACEBO_COMPARATOR

rTMS

Intervention Type PROCEDURE

Active session with stimulation and placebo session with fictive stimulation

Interventions

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rTMS

Active session with stimulation and placebo session with fictive stimulation

Intervention Type PROCEDURE

Other Intervention Names

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Active:A Placebo:B

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Rouen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne-Marie Leroi, phD

Role: PRINCIPAL_INVESTIGATOR

CHU Rouen

Locations

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Physiology Unit-Rouen university Hospital

Rouen, , France

Site Status

Countries

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France

Other Identifiers

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2007-A00799-44

Identifier Type: -

Identifier Source: secondary_id

2007/053/HP

Identifier Type: -

Identifier Source: org_study_id

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