Clinical trial NCT06757491: Two Weeks of rTMS in IBS
Official title: Repetitive Transcranial Magnetic Stimulation for 2 Weeks Reduces Visceral Pain in Patients With Irritable Bowel Syndrome.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Repetitive Transcranial Magnetic Stimulation
Chronic Visceral Pain
Functional Magnetic Resonance Imaging
IBS (Irritable Bowel Syndrome)
Clinical Efficacy
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Visceral Sensitivity Index
timeFrame: 2 weeks of treatment
Secondary outcomes:
measure: IBS-symptom severity score
timeFrame: 2 weeks of treatment
Other outcomes:
measure: anorectal manometry
timeFrame: 2 weeks of treatment
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital of Soochow University
name: Rui Li, Dr.
role: PRINCIPAL_INVESTIGATOR
References: