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Personalized Transcranial Magnetic Stimulation (TMS) for Metabolic Dysfunction and Alcohol-Related Liver Disease

Sponsored by The Affiliated Hospital of Hangzhou Normal University

About this trial

Last updated 4 months ago

Study ID

SJP20250926

Status

Not yet recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18 to 65 Years
All Sexes

Trial Timing

Started 4 months ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

* 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.

Exclusion Criteria

* Contraindications to magnetic resonance imaging (MRI) or transcranial magnetic stimulation (TMS).

* Mild cognitive impairment, defined as Montreal Cognitive Assessment (MoCA) score < 25.

* 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.