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

NCT ID: NCT06409078

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-11-19

Brief Summary

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.

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.

Conditions

Irritable Bowel Syndrome; Repetitive Transcranial Magnetic Stimulation; Chronic Visceral Pain; Functional Magnetic Resonance Imaging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

repeated transcranial magnetic stimulation group

The rTMS group was given 1 Hz/s for 20 min for 2 week.

Group Type: ACTIVE_COMPARATOR

rTMS group

Intervention Type: DEVICE

Patients with IBS-D received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 2 week.

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.

Group Type: SHAM_COMPARATOR

Sham device

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.

Interventions

rTMS group

Patients with IBS-D received repetitive transcranial magnetic stimulation at 1 Hz/s for 20 minutes for 2 week.

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

transcranial magnetic stimulation

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soochow University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Rui Li

Chief of the Department of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rui Li, Dr.

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Soochow University

Locations

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Countries

China

Other Identifiers

BE2023710

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

82470573

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024156

Identifier Type: -

Identifier Source: org_study_id