NCT01801605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
Last Updated

March 1, 2013

Status Verified

February 1, 2013

Enrollment Period

4.4 years

First QC Date

February 17, 2009

Last Update Submit

February 28, 2013

Conditions

Irritable Bowel Syndrome

Keywords

IBS - rectal hypersensitivity - rectal barostat - rTMS.

Outcome Measures

Primary Outcomes (1)

  • Pain or discomfort threshold volumes

    final (up to 5 days)

Secondary Outcomes (4)

  • Amplitude of R3 reflex

  • Visual analogic scale

  • Symptoms diary

  • Quality of life scores

Study Arms (2)

on

ACTIVE COMPARATOR

active session

Procedure: rTMS

off

PLACEBO COMPARATOR

fictive session

Procedure: rTMS

Interventions

rTMSPROCEDURE

Active session with stimulation and placebo session with fictive stimulation

Also known as: Active:A, Placebo:B
offon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 who could not stop the antalgic drugs within the week preceeding the onset of the study
  • patients with a significant lesion on RMI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physiology Unit-Rouen university Hospital

Rouen, France

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Anne-Marie Leroi, phD

    CHU Rouen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2009

First Posted

March 1, 2013

Study Start

August 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

March 1, 2013

Record last verified: 2013-02

Locations

FR(1)