Repeated Transcranial Magnetic Stimulation Relieve Chronic Visceral Pain in IBS

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · May 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called repeated Transcranial Magnetic Stimulation (rTMS) to see if it can help relieve chronic pain in patients with Irritable Bowel Syndrome (IBS). The goal is to find out how effective rTMS is compared to a common medication and to learn more about how it works in the brain. The trial will involve about 200 patients who have been diagnosed with IBS. They will be divided into two groups: one will receive rTMS treatment for one week, while the other will take a medication called pivinonium. Researchers will track improvements in symptoms like pain, mood, and sleep during the study.

To participate in this trial, individuals must be between 18 and 70 years old, have had IBS for more than six months, and meet specific diagnostic criteria for the condition. Participants should not have any serious other health issues or be using medications that could interfere with the study. Those who join can expect to receive either the rTMS treatment or the medication, and their progress will be monitored through assessments before and after the treatment. It's important to note that this study is still recruiting participants, so there are opportunities for eligible individuals to get involved.

Gender

ALL

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.