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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Soochow University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Repetitive Transcranial Magnetic Stimulation

    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.

  • Sham (No Treatment)

    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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Sham rTMS GroupSham comparator 1 intervention
Group B: rTMS GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visceral Sensitivity Index

(1) Clinical control: After the course of treatment, clinical symptoms disappear; (2) Significant effect: After the course of treatment, the symptom grading is reduced by 2 levels; (3) Effective: After the course of treatment, the symptom grading is reduced by 1 level; (4) Ineffective: After treatment, those who do not meet the above standards.

Time frame
2 weeks of treatment

Secondary outcomes

1

IBS-symptom severity score

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 bdominal 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.

Time frame
2 weeks of treatment

Other outcomes

1

anorectal manometry

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.

Time frame
2 weeks of treatment

Sponsors and contacts

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