Repetitive Transcranial Magnetic Stimulation in Irritable... | NCT01801605

Studies
Repetitive Transcranial Magnetic Stimulation in Irritable Bowel Syndrome

NCT01801605

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

Mar 1, 2013Estimated

Enrollment

20Actual

Phase

Phase 2

Conditions

Irritable Bowel Syndrome

Interventions

rTMS

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2007-A00799-44

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2008

Primary Completion Date

Jan 2013Actual

Completion Date

Jan 2013Actual

First Submitted Date

Feb 17, 2009

First Submission Date that Met QC Criteria

Feb 28, 2013

First Posted Date

Mar 1, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2013

Last Update Posted Date

Mar 1, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
on	Active Comparator	active session	Procedure: rTMS
off	Placebo Comparator	fictive session	Procedure: rTMS

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rTMS	Procedure	Active session with stimulation and placebo session with fictive stimulation	off on

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Amplitude of R3 reflex
Visual analogic scale
Symptoms diary

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne-Marie Leroi, phD	CHU Rouen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Physiology Unit-Rouen university Hospital		Rouen			France

Condition Browse Module

MeSH Terms

ID	Term
D043183	Irritable Bowel Syndrome

Ancestor Terms

ID	Term
D003109	Colonic Diseases, Functional
D003108	Colonic Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided