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Completed

NCT Number: NCT06409078

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rTMS group

Device

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 device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

  • Soochow University

Registry information

Official study title

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

Acronym: rTMS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 10, 2024
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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