Repetitive Transcranial Magnetic Stimulation in Irritable Bowel Syndrome

February 28, 2013 updated by: University Hospital, Rouen

Does Repetitive Transcranial Magnetic Stimulation (rTMS) Reduce Rectal Hypersensitivity in Patients With IBS ?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France
        • Physiology Unit-Rouen university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: on
active session
Procedure: rTMS
Active session with stimulation and placebo session with fictive stimulation
Other Names:
  • Active:A
  • Placebo:B
Placebo Comparator: off
fictive session
Procedure: rTMS
Active session with stimulation and placebo session with fictive stimulation
Other Names:
  • Active:A
  • Placebo:B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain or discomfort threshold volumes
Time Frame: final (up to 5 days)
final (up to 5 days)

Secondary Outcome Measures

Outcome Measure
Amplitude of R3 reflex
Visual analogic scale
Symptoms diary
Quality of life scores

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Anne-Marie LEROI, PhD, Chu Rouen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

February 17, 2009

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Estimate)

March 1, 2013

Last Update Submitted That Met QC Criteria

February 28, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/053/HP
  • 2007-A00799-44

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome

Clinical Trials on rTMS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe