NCT06409078

Repetitive Transcranial Magnetic Stimulation Attenuates Visceral Pain in Irritable Bowel Syndrome With Diarrhea

Clinical Study of Repeated Transcranial Magnetic Stimulation (rTMS) for Chronic Visceral Pain in Patients With Irritable Bowel Syndrome With Diarrhea (IBS-D)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: The First Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Objective: To identify a central hub of visceral pain in IBS-D and elucidate the mechanism by which repetitive transcranial magnetic stimulation (rTMS) confers analgesic effects. Design: Combined functional magnetic resonance imaging (fMRI) with visceral sensitivity assessments were used to pinpoint hyperactive brain regions of IBS-D patients. Therefore, a clinical trial was performed to validate the therapeutic potential of rTMS in IBS-D patients.

Detailed description

Background:Chronic visceral pain in irritable bowel syndrome with diarrhea (IBS-D) is a profound therapeutic challenge. While aberrant central processing is implicated, the key brain regions driving this visceral pain and their suitability as neuromodulatory targets remain undefined. Methods:Participants were randomly assigned (1:1) to the sham rTMS or rTMS group using a computer-generated randomization sequence created by an independent researcher who was not involved in recruitment, treatment, or outcome assessment. Allocation concealment was ensured using sequentially numbered, opaque, sealed envelopes, which were opened only after baseline evaluations were completed. Both participants and outcome assessors were blinded to treatment allocation. The rTMS operators were not involved in data collection or analysis. For the sham condition, the coil was positioned identically over the mPFC with magnetic output disabled, and prerecorded clicking sounds were delivered to mimic the acoustic sensation of stimulation. Participants were asked not to discuss treatment sensations with assessors. Scale raters and fMRI analysts remained blinded until all analyses were finalized. For the nested fMRI cohort, randomization and blinding procedures were identical, with group allocation revealed only after preprocessing and statistical analysis had been completed.

Conditions

• Irritable Bowel Syndrome
• Repetitive Transcranial Magnetic Stimulation
• Chronic Visceral Pain
• Functional Magnetic Resonance Imaging

Interventions

Type	Name	Description
DEVICE	rTMS group	Patients with IBS-D received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 2 week.
DEVICE	Sham device	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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-11-19
• Completion: 2025-11-19
• First posted: 2024-05-10
• Last updated: 2025-11-25

Locations

1 site across 1 country: China