Metabolic Dysfunction-Associated and Alcohol-Related Fatty Liver Disease
Conditions
Interventions
Individualized Treatment Protocol Based on Effective Brain Region NAc (A):Repetitive Transcranial Magnetic Stimulation (rTMS) with individualized precise targeting based on the effective brain region
iTBS parameters: 90% resting motor threshold, frequency 5Hz, 1800 pulses per burst, stimulation duration 570 seconds per session
total of 20 sessions, at least 2 times per week.
Control Group with '5 cm' Method Treatment Protocol (B):Repetitive Transcranial Magnetic Stimulation (rTMS) with traditional '5 cm' classic coordinate-based targeting
Sham Stimulation Treatment Protocol (C):Repetitive Transcranial Magnetic Stimulation (rTMS) with identical stimulation parameters to the trial and control group 1, but using only 10% resting motor thr
Sponsors
Affiliated Hospital of Hangzhou Normal University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The subjects were able to understand the content, requirements and limitations of the protocol, fully aware of the possible adverse reactions during the research process, willing to complete the follow-up as required, and voluntarily signed the informed consent form before the start of the study. 2. According to the "Guidelines for the Prevention and Treatment of Metabolism-related (Non-Alcoholic) Fatty Liver Disease (2024 Edition)", it meets the diagnostic criteria for MAFLD. According to the latest European definition criteria, the subjects were MetALD patients with moderate alcohol consumption (20-50g per day for females; 30-60 g per day for males). 3. Age 18-65 years old; 4. BMI greater than 24 kg/m^2. 25. No history of alcohol abuse.
Exclusion criteria
Exclusion criteria: 1. Individuals with contraindications to MRI or TMS; 2. Patients with mild cognitive impairment, Montreal Cognitive Assessment (MoCA) score < 25; 3. Severe other physical illnesses and neurological disorders; 4. Patients with psychiatric disorders, as well as those currently taking psychiatric medications; 5. Female patients who are pregnant, lactating, or planning to become pregnant; 6. Patients who have received TMS treatment within the past three months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in liver fat content (LFC) measured by MRI-PDFF at end of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in controlled attenuation parameter (CAP) and liver stiffness measurement (LSM) assessed by FibroScan VCTE;Change from baseline in liver fat content (LFC) measured by MRI-PDFF;Proportion of subjects with >=30% and >=50% reduction in liver fat content (LFC) from baseline;Change from baseline in liver function tests (ALT, AST, ALP, GGT, TBIL, ALB, PT, and INR);Proportion of subjects with >=17 U/L decrease in ALT from baseline;Change from baseline in glucose metabolism markers (HOMA-IR, HOMA-ß, HbA1c, FPG, and fasting insulin);Change from baseline in lipid metabolism markers (TG, TC, HDL-C, non-HDL-C, LDL-C, VLDL-C, Apo A1, Apo B, Lp(a), FFA);Change from baseline in body weight, body mass index (BMI), waist circumference, hip circumference, and waist-to-hip ratio;Change in alcohol-related indicators and food craving scale; | — |
Countries
China
Contacts
Public ContactShi Junping
Affiliated Hospital of Hangzhou Normal University
Outcome results
None listed