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

Soochow University

Status: Completed

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

Treatments: Device: Sham device; Device: rTMS group

Study type: Interventional

Funder types: Other

Identifiers

NCT06409078

2024156

82470573 (Other Grant/Funding Number)

BE2023710 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

repeated transcranial magnetic stimulation group

Active Comparator group

Description:

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

Treatment:

Device: rTMS group

sham repetitive transcranial magnetic stimulation group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham device