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

November 23, 2025 updated by: Rui Li, The First Affiliated Hospital of Soochow University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • the First Affiliated Hospital of Soochow University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria:1.Aged between 18 and 75 years (either sex); 2.A diagnosis of IBS-D according to the Rome IV criteria;3.Experience of Bristol stool type 6 or 7 on at least 4 days per week, with a mean abdominal pain score of ≥3 (on a 0-10 scale) during the 2-week screening period.

Exclusion criteria: 1.Inflammatory or organic gastrointestinal diseases; 2.Diabetes mellitus or hyperthyroidism; 3.History of previous anorectal, intestinal, or abdominal surgery; 4.Current use of medications known to alter gastrointestinal motility or secretion; 5.Pregnancy or lactation; 6.Metallic implants or presence of a cardiac pacemaker; 7.Noncompliance with randomized treatment allocation or demonstrated poor adherence to treatment protocols.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: repeated transcranial magnetic stimulation group
The rTMS group was given 1 Hz/s for 20 min for 2 week.
Device: rTMS group
Patients with IBS-D received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 2 week.
Other Names:
  • transcranial magnetic stimulation
Sham Comparator: sham repetitive transcranial magnetic stimulation group
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IBS-symptom severity score
Time Frame: Assessment time points were: baseline (1 week pre-treatment), end of the 2-week treatment, and post-treatment weeks 1, 2, 4, and 8.
The criteria were based on the IBS Symptom Severity Score (IBS-SSS), a hierarchical efficacy assessment method.The IBS-SSS consists of five entries assessing the degree of abdominal pain and discomfort, frequency of abdominal pain episodes, the degree of abdominal distension and discomfort, the degree of satisfaction with bowel habits and behaviors, and the degree of impact of intestinal symptoms on life,with a total score of 500 points. A score of 75-175 is considered mild, 176-300 is moderate, and over 300 is severe. Cure was defined as a total IBS symptom severity of less than 75; efficacy was defined as 2-level improvement in total score(e.g., symptoms improved from severe to mild); validity was defined as a 1-level improvement in tatal(e.g., symptoms improved from severe to moderate or symptoms from moderate to mild); and invalidity was defined as no improvement or deterioration in total score.
Assessment time points were: baseline (1 week pre-treatment), end of the 2-week treatment, and post-treatment weeks 1, 2, 4, and 8.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anorectal manometry
Time Frame: Assessment time points were: baseline (1 week pre-treatment), end of the 2-week treatment, and post-treatment weeks 4 and 8.
Anorectal manometry was performed on the subjects before and after treatment and the subjects' rectal primary sensory thresholds were recorded. Rectal initial sensory thresholds between 20-90ml were considered normal , less than 20ml was considered as sensitivity rectal sensory, and cure meant that the IBS patients had their rectal initial sensory recordings restored to between 20-90ml.
Assessment time points were: baseline (1 week pre-treatment), end of the 2-week treatment, and post-treatment weeks 4 and 8.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Visceral Sensitivity Index
Time Frame: Assessment time points were: baseline (1 week pre-treatment), end of the 2-week treatment, and post-treatment weeks 1, 2, 4, and 8.
The Visceral Sensitivity Index (VSI): the questionnaire is a 15-item scale used to assess visceral sensitivity. The total score ranges from 0 to 75 points, with higher scores indicating greater visceral sensitivity.
Assessment time points were: baseline (1 week pre-treatment), end of the 2-week treatment, and post-treatment weeks 1, 2, 4, and 8.
The Bristol Stool Form Scale (BSFS)
Time Frame: Assessment time points were: baseline (1 week pre-treatment), end of the 2-week treatment, and post-treatment weeks 1, 2, 4, and 8.
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.
Assessment time points were: baseline (1 week pre-treatment), end of the 2-week treatment, and post-treatment weeks 1, 2, 4, and 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

Soochow University

Investigators

  • Principal Investigator: Rui Li, Dr., the First Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2024

Primary Completion (Actual)

November 19, 2025

Study Completion (Actual)

November 19, 2025

Study Registration Dates

First Submitted

May 7, 2024

First Submitted That Met QC Criteria

May 7, 2024

First Posted (Actual)

May 10, 2024

Study Record Updates

Last Update Posted (Actual)

November 25, 2025

Last Update Submitted That Met QC Criteria

November 23, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024156
  • BE2023710 (Other Grant/Funding Number: Jiangsu Provincial Department of Science and Technology)
  • 82470573 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This clinical research protocol is just beginning to be studied at this time and sharing is not recommended at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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