Repetitive Transcranial Magnetic Stimulation in Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801605
• Other study ID #: 2007/053/HP
• Secondary ID: 2007-A00799-44
• Status: Completed
• Phase: Phase 2
• First received: February 17, 2009
• Last updated: February 28, 2013
• Start date: August 2008
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver)

Related Conditions & MeSH terms

• Hypersensitivity
• Irritable Bowel Syndrome

Intervention

Procedure:
• rTMS
Active session with stimulation and placebo session with fictive stimulation

Locations

Country	Name	City	State
France	Physiology Unit-Rouen university Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain or discomfort threshold volumes		final (up to 5 days)	No
Secondary	Amplitude of R3 reflex
Secondary	Visual analogic scale
Secondary	Symptoms diary
Secondary	Quality of life scores