Low-frequency rTMS to reduce belly pain in diarrhea-predominant IBS
Low-frequency Repetitive Transcranial Magnetic Stimulation Attenuates Visceral Pain in Irritable Bowel Syndrome With Diarrhea Via Inhibition of the Medial Prefrontal Cortex
This trial tests whether low-frequency repetitive transcranial magnetic stimulation (rTMS) to a brain region can reduce visceral (belly) pain in adults with IBS-D.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital of Soochow University Academic / other |
| Locations | 1 site (Suzhou, Jiangsu) |
| Trial ID | NCT06757491 on ClinicalTrials.gov |
What this trial studies
In a randomized, sham-controlled, double-blind design, 42 adults with diarrhea-predominant IBS were assigned 1:1 to active low-frequency rTMS or sham over the medial prefrontal cortex for a two-week intervention. A nested cohort of 21 participants underwent baseline functional MRI to identify central pain hubs and to explore neural mechanisms of analgesia. Allocation was concealed with opaque envelopes and both participants and outcome assessors were blinded; rTMS operators were separated from outcome assessment. Outcomes combined clinical pain measures and fMRI analyses to link symptom change with brain activity.
Who should consider this trial
Good fit: Adults aged 18–75 who meet Rome IV criteria for IBS with diarrhea, without organic GI disease, major psychiatric disorders, recent relevant surgery, pregnancy/lactation, or incompatible implants are ideal candidates.
Not a fit: People with constipation-predominant IBS, inflammatory or other organic gastrointestinal disease, certain psychiatric diagnoses, pregnancy, or implanted metal/pacemakers were excluded and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide a non-drug, brain-targeted option to reduce chronic visceral pain in people with IBS-D.
How similar studies have performed: Previous rTMS studies for chronic pain and a few small trials in IBS suggest potential benefit, but targeting the medial prefrontal cortex for visceral pain is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
All diagnoses were made by board-certified gastroenterologists. Eligible participants met the following inclusion criteria: (1) age between 18 and 75 years; (2) fulfillment of the Rome IV diagnostic criteria for IBS-D. Exclusion criteria included: (1) presence of inflammatory or other organic gastrointestinal diseases; (2) diagnosed psychiatric disorders; (3) history of anorectal, intestinal, or abdominal surgery; (4) pregnancy or lactation; (5) presence of metallic implants or cardiac pacemakers.
Where this trial is running
Suzhou, Jiangsu
- The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Rui Li, Dr. — The First Affiliated Hospital of Soochow University
- Study coordinator: Ruixia Weng, Dr.
- Email: wengruixia@suda.edu.cn
- Phone: 15206214921
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.