Repeated Transcranial Magnetic Stimulation for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Clinical Trial
Repeated Transcranial Magnetic Stimulation (rTMS) for the Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Randomized Clinical Trial
The First Affiliated Hospital of Soochow University
46 participants
Dec 1, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- Eligible participants had to be between 18- 60 years of age and fulfill the Rome IV criteria for IBS-D. Specifically, patients must have experienced recurrent abdominal pain at least one day per week in the last three months, with symptom onset at least six months prior to diagnosis, associated with defecation or a change in the frequency or form (appearance) of stool. More than 25% of stool episodes be classified as Bristol Stool Form Scale (BSFS) type 6 or 7, and fewer than 25% as type 1 or 2. In addition, patients were required to exhibit moderate to severe symptoms, defined as an Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) score greater than 175 (on a 500-point scale). Dietary preferences of all participants included non vegetarian options and participants maintain stable dietary habits for at least one month prior to randomization. Moreover, patients aged over 50 were required to provide documentation of a normal colonoscopy performed within the preceding three years.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Patients with IBS-D received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 3 weeks.
For 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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07581756