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Completed

NCT Number: NCT01801605

Repetitive Transcranial Magnetic Stimulation in Irritable Bowel Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Physiology Unit-Rouen university Hospital

Rouen, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rTMS

Procedure

Active session with stimulation and placebo session with fictive stimulation

Other names: Active:A, Placebo:B

Primary outcomes

  1. Pain or discomfort threshold volumes

    Time frame: final (up to 5 days)

Secondary outcomes

  1. Amplitude of R3 reflex

  2. Visual analogic scale

  3. Symptoms diary

  4. Quality of life scores

Sponsors and collaborators

Lead sponsor

University Hospital, Rouen

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2013
Study completion
2013
First posted
Mar 1, 2013
Registry last updated
Mar 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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