Lf-rTMS Attenuates Visceral Pain in Irritable Bowel Syndrome With Diarrhea
NCT06757491 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2025-11-21
Summary
Objectives: 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.
Methods: A total of 42 IBS-D patients were recruited and randomly assigned (1:1) to the sham rTMS or the rTMS group. A nested cohort of 21 IBS-D participants who completed baseline fMRI assessments prior to randomization was included. Consistent with the randomization procedure,these individuals were evenly distributed between the two groups. Both participants and outcome assessors remained blinded to treatment allocation throughout the study. All patients completed the two-week intervention and were included in the final analysis.
Conditions
- Repetitive Transcranial Magnetic Stimulation
- Chronic Visceral Pain
- Functional Magnetic Resonance Imaging
- IBS (Irritable Bowel Syndrome)
- Clinical Efficacy
Interventions
- DEVICE
-
Repetitive Transcranial Magnetic Stimulation
A figure-of-eight coil is used to apply active low-frequency (1 Hz) rTMS to the corresponding representation area of theprefrontal cortex (mPFC). The treatment is administered for 20 minutes daily for a total of 2 weeks.
- DEVICE
-
Sham (No Treatment)
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.
Sponsors & Collaborators
-
The First Affiliated Hospital of Soochow University
lead OTHER
Principal Investigators
-
Rui Li, Dr. · The First Affiliated Hospital of Soochow University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-01
- Primary Completion
- 2025-12-25
- Completion
- 2026-01-25
Countries
- China
Study Locations
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