Physiology Unit-Rouen university Hospital
Rouen, France
NCT Number: NCT01801605
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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Notify Me18 year and older
All sexes
Interventional
Phase 2
Rouen, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Active session with stimulation and placebo session with fictive stimulation
Other names: Active:A, Placebo:B
Time frame: final (up to 5 days)
University Hospital, Rouen
Other
Does Repetitive Transcranial Magnetic Stimulation (rTMS) Reduce Rectal Hypersensitivity in Patients With IBS ?
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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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