Repetitive Transcranial Magnetic Stimulation in Irritable Bowel Syndrome
NCT ID: NCT01801605
Last Updated: 2013-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
20 participants
INTERVENTIONAL
2008-08-31
2013-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DOUBLE
Study Groups
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on
active session
rTMS
Active session with stimulation and placebo session with fictive stimulation
off
fictive session
rTMS
Active session with stimulation and placebo session with fictive stimulation
Interventions
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rTMS
Active session with stimulation and placebo session with fictive stimulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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University Hospital, Rouen
OTHER
Responsible Party
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Principal Investigators
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Anne-Marie Leroi, phD
Role: PRINCIPAL_INVESTIGATOR
CHU Rouen
Locations
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Physiology Unit-Rouen university Hospital
Rouen, , France
Countries
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Other Identifiers
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2007-A00799-44
Identifier Type: -
Identifier Source: secondary_id
2007/053/HP
Identifier Type: -
Identifier Source: org_study_id
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