NCT07399600尚未招募不适用
Personalized Transcranial Magnetic Stimulation for Metabolic Dysfunction and Alcohol-Related Liver Disease (MetALD): A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial
The Affiliated Hospital of Hangzhou Normal University1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2026年2月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Percent Change in Liver Fat Content (LFC) From Baseline to End of Treatment as Measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
研究概览
简要总结
The goal of this clinical trial is to learn if repetitive Transcranial Magnetic Stimulation (rTMS), a non-invasive brain stimulation technique, works to treat Metabolic dysfunction-associated and alcohol-associated liver disease (MetALD). The main questions it aims to answer are:
- Can rTMS effectively treat MetALD?
- Is an individualized, precision-targeted rTMS approach more effective than the standard rTMS method?
- What changes in brain activity are associated with the treatment?
Researchers will compare three different types of stimulation:
- Group A: Individualized rTMS targeting a deep brain reward area (the Nucleus Accumbens) based on each participant's brain scan (fMRI).
- Group B: Standard rTMS applied using the traditional "5 cm" rule for positioning.
- Group C: Sham (placebo) rTMS, which mimics the procedure but delivers no significant magnetic stimulation.
Participants will:
- Be randomly assigned to one of the three groups (A, B, or C).
- Undergo an MRI brain scan before starting treatment.
- Receive a total of 20 rTMS sessions, completing at least 4 sessions per week.
- Have additional MRI scans and clinical assessments halfway through and immediately after the treatment course.
- Attend follow-up visits at 1, 3, and 6 months after treatment completion to assess long-term effects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants are able to understand the study protocol, requirements, and restrictions, are fully informed of potential adverse events, are willing to comply with follow-up visits, and voluntarily sign the informed consent form before enrollment.
- •Meet the diagnostic criteria for MASLD according to the Guidelines for the Prevention and Treatment of Metabolic (Non-Alcoholic) Fatty Liver Disease (2024 Edition), and fulfill the European definition of MetALD with moderate alcohol consumption (20-50 g/day for women; 30-60 g/day for men).
- •Age between 18 and 65 years.
- •Body mass index (BMI) > 24 kg/m².
- •No history of alcohol abuse.
排除标准
- •Contraindications to magnetic resonance imaging (MRI) or transcranial magnetic stimulation (TMS).
- •Mild cognitive impairment, defined as Montreal Cognitive Assessment (MoCA) score <
- •Severe comorbid somatic diseases or neurological disorders.
- •History of psychiatric disorders, or current use of antipsychotic medications.
- •Pregnant or breastfeeding women, or those planning pregnancy.
- •Previous TMS treatment within the last 3 months.
研究组 & 干预措施
Conventional rTMS
Active Comparator
干预措施: Conventional rTMS (Device)
Sham rTMS
Sham Comparator
干预措施: Transcranial Magnetic Stimulation Sham (Device)
Active rTMS
Experimental
干预措施: Individually Targeted rTMS (Device)
结局指标
主要结局
Percent Change in Liver Fat Content (LFC) From Baseline to End of Treatment as Measured by Magnetic Resonance Imaging-Proton Density Fat Fraction (MRI-PDFF)
时间窗: From baseline to the end of treatment (Week 4)
次要结局
- Change in Controlled Attenuation Parameter (CAP, dB/m) From Baseline as Assessed by Vibration-Controlled Transient Elastography (FibroScan® VCTE)(From baseline to mid-treatment (Week 2), end of treatment (Week 4), and at 1-, 3-, and 6-month follow-up)
- Change in Liver Stiffness Measurement (LSM, kPa) From Baseline as Assessed by FibroScan® VCTE(From baseline to mid-treatment (Week 2), end of treatment (Week 4), and at 1-, 3-, and 6-month follow-up)
- LFC From Baseline as Measured by MRI-PDFF(From baseline to the end of treatment (Week 4))
- Proportion of Participants Achieving ≥30% or ≥50% Reduction in LFC From Baseline(From baseline to the end of treatment (Week 4))
- Change in Serum Levels of Liver Enzymes (ALT, AST, ALP, GGT [U/L]) From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Serum Level of Albumin From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in International Normalized Ratio (INR) From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Prothrombin Time (PT) From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Serum Level of Total Bilirubin (TBIL) From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Proportion of Participants With ALT Reduction >17 U/L From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Glucose Metabolism Markers (HOMA-IR [Index]; HOMA-β [Index]) From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Glucose Metabolism Markers (HbA1c [%]) From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Fasting Plasma Glucose (FPG) From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Fasting Insulin From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Concentration of Conventional Lipid Panel (TC, TG, HDL-C, LDL-C, non-HDL-C, VLDL-C [mmol/L]) From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Concentration of Apolipoproteins (Apo A1, Apo B [g/L]) From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Serum Lipoprotein(a) (Lp(a)) Concentration From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Serum Free Fatty Acids (FFA) Concentration From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Body Weight [kg] From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in BMI [kg/m²] From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Body Circumferences (Waist, Hip) [cm] From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Waist-to-Hip Ratio From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in General Food Craving Questionnaire-Trait (G-FCQ-T) Total Score From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in General Food Craving Questionnaire-State (G-FCQ-S) Total Score From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Score on Visual Analogue Scale (VAS) for Subjective Food Craving From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Caloric intake recorded by the Mint Health App From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Alcohol Use Disorders Identification Test (AUDIT) Score From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Penn Alcohol Craving Scale (PACS) Score From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
- Change in Alcohol Consumption Assessed by the Timeline Followback (TLFB) Method From Baseline(baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months)
研究者
研究点 (1)
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