- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01801605
Repetitive Transcranial Magnetic Stimulation in Irritable Bowel Syndrome
Does Repetitive Transcranial Magnetic Stimulation (rTMS) Reduce Rectal Hypersensitivity in Patients With IBS ?
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
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Rouen, France
- Physiology Unit-Rouen university Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: on
active session
|
Active session with stimulation and placebo session with fictive stimulation
Other Names:
|
Placebo Comparator: off
fictive session
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Active session with stimulation and placebo session with fictive stimulation
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain or discomfort threshold volumes
Time Frame: final (up to 5 days)
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final (up to 5 days)
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Secondary Outcome Measures
Outcome Measure |
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Amplitude of R3 reflex
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Visual analogic scale
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Symptoms diary
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Quality of life scores
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne-Marie LEROI, PhD, CHU Rouen
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2007/053/HP
- 2007-A00799-44
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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