Objectives: This study aims to evaluate the clinical efficacy and safety of repetitive transcranial magnetic stimulation (rTMS) in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), and to explore the potential underlying mechanisms by which rTMS alleviates clinical symptoms in IBS-D patients.
Design: This is a clinical trial that uses clinical symptom scales to assess the therapeutic effect of rTMS on IBS-D patients. Meanwhile, gut microbiota and metabolite profiling, as well as the methane-hydrogen breath test, will be applied to investigate the mechanism of action from the perspectives of gut microecology, intestinal motility, and metabolism, so as to provide scientific evidence for the clinical application of rTMS in the treatment of IBS-D.
None
None
Parallel
rTMS group
DevicePatients with IBS-D received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 3 weeks.
sham device
DeviceFor the sham rTMS group, the coil was placed over the mPFC with the rTMS function disabled, and pre-recorded acoustic artifacts were played to mimic the auditory experience of the rTMS group.
Composite response rate
The primary outcome measure of this study is the composite response rate on Day 14 of treatment; a composite responder is defined as having both a ≥30% reduction in the weekly average of the worst abdominal pain intensity in the past 24 hours compared with baseline and a ≥50% reduction in the weekly number of days with Bristol Stool Form Scale (BSFS) Type 6 or 7 (diarrheal stools) compared with baseline.
Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS)
Changes in the total score of the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) from baseline to Day 21. The IBS-SSS ranges from 0 to 500 points and covers five domains: severity and frequency of abdominal pain, bloating, satisfaction with bowel habits, and impact on quality of life. A reduction of ≥95 points is considered a clinically meaningful improvement.
Irritable Bowel Syndrome Quality of Life (IBS-QOL)
IBS-QOL is a validated questionnaire assessing quality of life in IBS patients. Scores range 0-100; higher scores reflect better quality of life. A ≥14-point increase indicates clinically significant improvement.
The Bristol Stool Form Scale (BSFS) and Frequency of defecation
The Bristol Stool Form Scale (BSFS): it is adopted to assess bowel habits, with scores from 1 to 7 corresponding to stool types ranging from hardest to softest, where higher scores indicate more severe diarrhea.
Numeric Rating Scale (NRS)
Numeric Rating Scale (NRS) is an 11-point pain rating scale (0 = no pain, 10 = worst pain). A ≥30% decrease in NRS score indicates clinically significant pain relief.
Click on the lead sponsor to view all of their trials.
