Using magnetic stimulation to relieve chronic pain in IBS

Clinical Study of Repeated Transcranial Magnetic Stimulation(rTMS) for Chronic Visceral Pain in Patients With Irritable Bowel Syndrome(IBS)

This study is testing if a treatment called magnetic stimulation can help people with irritable bowel syndrome (IBS) feel less pain and improve their overall quality of life.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (other)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06409078 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy of repeated transcranial magnetic stimulation (rTMS) in treating chronic visceral pain associated with irritable bowel syndrome (IBS). A total of 200 IBS patients will be randomized into two groups: one receiving rTMS treatment and the other receiving standard Western medicine for one week. The study will assess changes in symptoms, stool characteristics, mood, and sleep quality, while also exploring the underlying mechanisms of rTMS using functional magnetic resonance imaging (fMRI). The goal is to determine whether rTMS can effectively alleviate IBS symptoms and improve patients' quality of life.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 who have been diagnosed with IBS and have experienced symptoms for more than six months.

Not a fit: Patients with severe underlying health conditions or those with clear organic diseases of the intestinal tract may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive option for managing chronic pain in IBS patients.

How similar studies have performed: Previous studies have indicated that rTMS can relieve chronic pain, suggesting potential success for this approach in IBS treatment.

Eligibility criteria

Inclusion Criteria:

1. Must meet the diagnostic criteria for Irritable Bowel Syndrome of Rome IV.
2. Age range between 18-70 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 70 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: ① regular use of preparations and drugs affecting gastrointestinal dynamics or function; ② 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.

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Principal investigator: Rui Li — The First Affiliated Hospital of Soochow University
• Study coordinator: Ruixia Weng

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