Lf-rTMS Attenuates Visceral Pain in Irritable Bowel Syndrome With Diarrhea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-01-25

Brief Summary

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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.

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Detailed Description

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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

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Repetitive Transcranial Magnetic Stimulation Chronic Visceral Pain Functional Magnetic Resonance Imaging IBS (Irritable Bowel Syndrome) Clinical Efficacy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sham rTMS 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.

Group Type SHAM_COMPARATOR

Sham (No Treatment)

Intervention Type 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.

rTMS Group

Low-frequency rTMS (1 Hz) was applied to the mPFC using a TMS stimulator at 80% resting motion threshold intensity.

Group Type ACTIVE_COMPARATOR

Repetitive Transcranial Magnetic Stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No