Two Weeks of rTMS in IBS

Not Applicable

Active, not recruiting

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

• Registration Number: NCT06757491
• Lead Sponsor: The First Affiliated Hospital of Soochow University

Brief Summary

Objectives: To evaluate the clinical efficacy of repetitive transcranial magnetic stimulation (rTMS) in the treatment of Irritable Bowel Syndrome (IBS), and simultaneously, explore the central mechanisms of rTMS treatment for IBS based on brain functional magnetic resonance imaging (fMRI).

Methods: The functional changes in specific brain regions of IBS patients were assessed using fMRI before and after treatment, and the clinical efficacy of rTMS treatment was evaluated using visceral sensitivity index scores, IBS-SSS scores, and anorectal manometry.

Detailed Description

A large number of literature has reported that repetitive transcranial magnetic stimulation(rTMS) can relieve chronic pain. The specific mechanisms include that rTMS can change the excitability of the cerebral cortex, improve cerebral blood flow and metabolism, regulate neurotransmitter and gene expression, and plastic changes in the nervous system. Methods: Functional MRI (fMRI) data were collected from 100 participants (50 IBS patients and 50 healthy controls) during rectal balloon distention at a volume of 120 mL. The amplitude of low-frequency fluctuation (ALFF) was used to analyze the fMRI data, comparing brain functional differences between IBS patients and healthy controls. Changes in ALFF values across brain regions were correlated with clinical observation indicators to identify targeted areas for rTMS. Based on these findings, rTMS interventions targeting the identified brain areas were applied in IBS patients. Changes in brain function before and after treatment were assessed to evaluate the clinical efficacy of rTMS.

Study Timeline

• Study Start: 2024-04-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-24
• Study First Submitted QC: 2024-12-24
• Last Update Submitted: 2024-12-24
• Study First Posted: 2025-01-03
• Last Update Posted: 2025-01-03
• Primary Completion: 2026-01-25
• Study Completion: 2026-01-25

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Must meet the diagnostic criteria for Irritable Bowel Syndrome of Rome IV.
2. Age range between 18-60 years.
3. The duration of the disease is more than 6 months.
4. There are no pathologic abnormalities or biochemical changes that could explain the bowel-related symptoms.
5. The IBS symptom severity score at baseline must not be less than 75.
6. No pharmacological treatment (excluding emergency treatment) for IBS for at least 2 weeks prior to the start of treatment; no concurrent participation in other clinical programs.
7. Voluntarily sign the relevant informed consent form and voluntarily participate in this clinical project.

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Exclusion Criteria

1. Be less than 18 years old or more than 60 years old.
2. Those who suffer from severe liver, kidney, hematopoietic system diseases, cardiovascular and cerebrovascular diseases, and psychiatric diseases that significantly affect cognitive function.
3. Patients with clear organic diseases of the intestinal tract; patients with diabetes, hyperthyroidism and other systemic diseases that affect the digestive tract dynamics; patients who have had a history of surgery on the anus and intestines or the abdomen.
4. The presence of the following conditions affecting the efficacy or safety judgment: # regular use of preparations and drugs affecting gastrointestinal dynamics or function; # treatment with other treatments and drugs that may affect the results of the judgment.
5. Those who are pregnant, breastfeeding or less than 12 months after delivery.
6. Patients with severe fear of needles, metal allergies or sensitivities, or those with pacemakers.
7. Patients who do not comply with the randomized assignment to the treatment group or have a tendency to be unstable such as poor compliance.
8. Patients who are participating in other research projects.
9. Those who do not want to sign the informed consent form.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Visceral Sensitivity Index	2 weeks of treatment	(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.

Secondary Outcome Measures

Name	Time	Method
IBS-symptom severity score	2 weeks of treatment	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.

Trial Locations

Locations (1)

The First Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China