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

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

Objective: To evaluate the overall efficacy of rTMS in the treatment of irritable bowel syndrome and to explore the central mechanism of rTMS for IBS.

Methods: 1. Clinical efficacy evaluation of TMS for chronic visceral pain in IBS patients The 200 IBS patients who meet the recruitment criteria for the clinical study will be randomized into 100 patients in rTMS and Western medicine group. Corresponding treatment was given for 1 week, rTMS group received 1 Hz/s, 20 min for 1 week; Western medicine group received pivinonium tablets orally, 50 mg three times a day for 1 week. Clinical assessment included symptoms, stool traits, mood, and sleep. 2. Study on the central mechanism of using fMRI to treat chronic visceral pain in IBS patients Forty cases each were included in the IBS-eligible patient group and the healthy control group, and repeated transcranial magnetic stimulation treatment was given to the patient group for 1 week, and the patient group underwent the assessment of clinical observational indexes (IBS-SSS, SAS, SDS, and AIS) before and after the treatment and the acquisition of functional magnetic resonance data. In the healthy control group, clinical observation indexes (SAS, SDS, AIS) were evaluated before enrollment, and functional magnetic resonance data were collected after enrollment.

Conclusion: 1. The clinical efficacy of rTMS for IBS is superior to that of the western drug pivoxyl bromide tablets. 2. Targeted brain areas of rTMS treatment: there was a positive correlation between the change in ALFF values of mPFC and the improvement in abdominal pain level score before and after treatment.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• Must meet the diagnostic criteria for Irritable Bowel Syndrome of Rome IV.

• Age range between 18-70 years.

• The duration of the disease is more than 6 months.

• There are no pathologic abnormalities or biochemical changes that could explain the bowel-related symptoms.

• The IBS symptom severity score at baseline must not be less than 75.

• 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.

• Voluntarily sign the relevant informed consent form and voluntarily participate in this clinical project.

Locations
Other Locations
China
The First Affiliated Hospital of Soochow University
RECRUITING
Suzhou
Contact Information
Primary
Ruixia Weng
20227832021@stu.suda.edu.cn
13771725877
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 200
Treatments
Experimental: repeated transcranial magnetic stimulation treatment group
The rTMS group was given 1 Hz/s for 20 min for 1 week.
Experimental: Western medicine group
The western medicine group was given pivacurium bromide tablets orally at 50 mg three times daily for 1 week.
Sponsors
Leads: The First Affiliated Hospital of Soochow University
Collaborators: Soochow University

This content was sourced from clinicaltrials.gov

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