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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Individualized TMS Intervention, Sham TMS Intervention.
- Who it may be relevant to
- Registry conditions: Irritable Bowel Syndrome (IBS), Pain, Depressive Disorder, Major, Moderate. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Device 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 pul - Device 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 orie
Primary outcome measures
- Irritable Bowel Syndrome Symptom Severity Rating Scale (IBS-SSS) [Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)]
Secondary outcome measures (9)
- Fecal microbiota composition [Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session)]
- Fecal Metabolic Profile [Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session)]
- Visual Analogue Scale (VAS) for Pain [Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)]
- Short-Form McGill Pain Questionnaire (SF-MPQ) [Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)]
- Irritable Bowel Syndrome Quality of Life Scale (IBS-QOL) [Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)]
- 17 items-Hamilton Depression Rating Scale (HAMD-17) [Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)]
- 14 items-Hamilton Anxiety Rating Scale (HAMA-14) [Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)]
- Brain Function Features (Multimodal MRI) [Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)]
- Brain Structure Features (Multimodal MRI) [Time frame: Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session), 1 month after treatment (±7 days), 3 months after treatment (±7 days)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The affiliated hospital of Hangzhou Normal University — Hangzhou
Identifiers
NCT: NCT07345377 · 2024(E2)-HS-009