Study on Treatment Mechanisms and Efficacy Prediction of Individualized Transcranial Magnetic Stimulation in Adults With Irritable Bowel Syndrome Using Multimodal MRI and High-Throughput Sequencing

The Affiliated Hospital of Hangzhou Normal University

Status

Invitation-only

Conditions

Depressive Disorder, Major, Moderate

Irritable Bowel Syndrome (IBS)

Pain

Treatments

Device: Individualized TMS Intervention

Device: Sham TMS Intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT07345377

2024(E2)-HS-009

Details and patient eligibility

About

The goal of this clinical trial is to explore if "individualized repetitive Transcranial Magnetic Stimulation (TMS)" works to improve symptoms in adults with Irritable Bowel Syndrome (IBS). It also aims to learn how this treatment works (by looking at links between the brain, gut, and gut bacteria) and if tests like brain scans or gut bacteria checks can show if the treatment will work for a person. The main questions it aims to answer are:

Will individualized TMS improve IBS symptoms (like stomach pain or discomfort) and affect the links between the brain, gut, and gut bacteria? Can brain scan results (from multimodal Magnetic Resonance Imaging, MRI) and gut bacteria checks (from high-throughput sequencing) predict how well a person responds to TMS?

Participants will be adults aged 18-59 who:

Meet the Rome Ⅳ criteria for IBS (a standard way to diagnose IBS); Have stopped taking IBS-related medicines for more than 2 weeks; Do NOT have MRI or TMS contraindications (like metal implants in the body, mental illness, pregnancy, or serious illnesses requiring hospital stays).

Participants will:

Receive 10 TMS sessions (5 times a week, for 2 weeks total) - TMS is a non-invasive treatment that uses gentle magnetic pulses on the scalp;

Before the first TMS session, and again after the 10th session:

Fill out surveys to rate IBS symptoms; Have an MRI scan (painless, takes about 60 minutes) to look at brain activity; Provide a small stool sample to check gut bacteria.

Enrollment

160 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Meets the Rome IV diagnostic criteria for Irritable Bowel Syndrome (IBS);
Has discontinued IBS-related medications for more than 2 weeks prior to enrollment;
Aged between 18 and 75 years (inclusive);
Has sufficient cognitive ability to provide informed consent, understand study instructions, and complete questionnaires.

Exclusion criteria

Has contraindications to MRI (e.g., metal implants in the body, claustrophobia) or TMS (e.g., history of epilepsy, skull defects);
Diagnosed with mental illnesses (e.g., schizophrenia, bipolar disorder) that require ongoing medication or psychotherapy;
Women who are pregnant, breastfeeding, or planning to become pregnant during the study period;
Presents signs of severe illness requiring hospitalization (e.g., hemodynamic instability, acute infection, acute myocardial infarction, cerebral infarction);
Has taken any substances that may affect study indicators (e.g., probiotics, prebiotics) within 3 months prior to enrollment.