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
概览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- The Affiliated Hospital of Hangzhou Normal University
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Irritable Bowel Syndrome Symptom Severity Rating Scale (IBS-SSS)
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Irritable Bowel Syndrome Symptom Severity Rating Scale (IBS-SSS)
时间窗: 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)
Assessment of the severity of irritable bowel syndrome symptoms (including abdominal pain, bloating, diarrhea/constipation, and impact on daily life) using the IBS-SSS. Scale Details: Minimum value: 0 points; Maximum value: 500 points; Score interpretation: Higher scores indicate more severe IBS symptoms.
17 items-Hamilton Depression Rating Scale (HAMD-17)
时间窗: 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)
Assessment of the severity of depressive symptoms in participants using the 17-item Hamilton Depression Rating Scale. Scale Details: Minimum value: 0 points; Maximum value: 54 points; Score interpretation: Higher scores indicate more severe depressive symptoms.
14 items-Hamilton Anxiety Rating Scale (HAMA-14)
时间窗: 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)
Assesses the severity of anxiety symptoms in participants, covering both psychological anxiety dimensions (e.g., tension, fear, restlessness) and somatic anxiety dimensions (e.g., palpitations, muscle soreness, gastrointestinal discomfort). Scale Details: Minimum value: 0 points; Maximum value: 56 points; Score interpretation: Higher scores indicate more severe anxiety symptoms.
Brain Structure Features (Multimodal MRI)
时间窗: 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)
Assessment of brain structural indicators including gray matter volume (measured by voxel-based morphometry) and white matter integrity (measured by fractional anisotropy via diffusion tensor imaging).
Brain Function Features (Multimodal MRI)
时间窗: 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)
Assessment of brain functional indicators covering multiple dimensions of neural activity and circuit organization: * Spontaneous brain activity: Quantifies the intensity and synchronization of intrinsic resting-state neural activity, including: Amplitude of low-frequency fluctuations (ALFF); Regional Homogeneity (ReHo). * Functional connectivity: Measures inter-regional neural associations, including: Seed-based correlation analysis; Dynamic Causal Modeling (DCM). * Brain network organization: Analyzes large-scale circuit integration, including: Independent Component Analysis (ICA); Brain network topology. The above are representative indicators; other relevant brain functional metrics may be included as needed.
次要结局
- Fecal microbiota composition(Baseline (within 1 week before the first TMS session), post-treatment (within 24 hours after the 10th TMS session))
- Fecal Metabolic Profile(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(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)(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)(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))