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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
Sponsor: The Affiliated Hospital of Hangzhou Normal University
Summary
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.
Official title: Exploratory Clinical Study to Investigate the Therapeutic Mechanisms, Efficacy Prediction, and Safety Profile of Individualized Transcranial Magnetic Stimulation as a Therapeutic Intervention in Adult Participants Diagnosed With Irritable Bowel Syndrome, Utilizing Multimodal Magnetic Resonance Imaging for Neuroimaging Assessment and High-Throughput Sequencing for Fecal Microbiota Analysis and Metabolic Profile Detection
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2022-01-01
Completion Date
2028-12
Last Updated
2026-01-15
Healthy Volunteers
No
Interventions
Individualized TMS Intervention
This individualized transcranial magnetic stimulation (TMS) intervention distinguishes itself from conventional fixed-target TMS by using resting-state fMRI functional connectivity to determine the personalized left dorsolateral prefrontal cortex (DLPFC) target. It uses a Magstim TMS system (infrared optical navigation) for precise positioning. Stimulation intensity is 90% of the individual's resting motor threshold (RMT; MEPs \>50μV in ≥5/10 stimulations), delivered via the iTBS paradigm (3 pulses/burst \[50Hz\], 5Hz burst repetition, 2s stimulation/8s rest, 3 cycles/1800 pulses per session). This personalized targeting design enhances precision, setting it apart from non-individualized TMS in other studies.
Sham TMS Intervention
This sham TMS intervention is designed to maintain double-blinding: it uses the same equipment (Magstim infrared navigation TMS system), procedures (individual RMT measurement, personalized left DLPFC target positioning), iTBS paradigm (3 pulses/burst \[50Hz\], 5Hz repetition, 2s/8s cycle, 1800 pulses/session) and duration (20min core/40min total per session, 10 total sessions) as the individualized TMS in this study. Its only distinction (from the experimental intervention) is the 90° coil orientation (directing magnetic field away from the scalp, no effective cortical stimulation).
Locations (1)
The affiliated hospital of Hangzhou Normal University
Hangzhou, Zhejiang, China