Personalized Transcranial Magnetic Stimulation (TMS) for Metabolic Dysfunction and Alcohol-Related Liver Disease
P-TMS MetALD
1 other identifier
interventional
105
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedFirst Posted
Study publicly available on registry
February 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
February 10, 2026
January 1, 2026
1.6 years
November 17, 2025
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
From baseline to the end of treatment (Week 4)
Secondary Outcomes (29)
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
- +24 more secondary outcomes
Other Outcomes (2)
Resting-State Functional Connectivity (rs-FC) Measured by fMRI
From baseline to mid-treatment (Week 2) and end of treatment (Week 4)
Amplitude of Low-Frequency Fluctuations (ALFF) Measured by fMRI
From baseline to mid-treatment (Week 2) and end of treatment (Week 4)
Study Arms (3)
Conventional rTMS
ACTIVE COMPARATORSham rTMS
SHAM COMPARATORActive rTMS
EXPERIMENTALInterventions
Participants will receive individualized transcranial magnetic stimulation (TMS) based on neuroimaging-guided localization of the nucleus accumbens (NAc). After the first MRI scan, participants will be randomized by an independent researcher responsible for data analysis. The individualized stimulation coordinates will be provided to the TMS operator before treatment. Intervention will be delivered using intermittent theta-burst stimulation (iTBS): the coil will be placed tangentially to the scalp over the individualized target. Stimulation parameters: 90% resting motor threshold (RMT); bursts of 3 pulses at 50 Hz; bursts repeated at 5 Hz; a total of 1800 pulses per session; stimulation duration 570 seconds. Each participant will receive 20 sessions in total, with at least 2 treatment days per week (2 sessions/day, 4 sessions/week). MRI and clinical assessments will be repeated at mid-treatment and after treatment completion, with follow-up clinical evaluations at 1, 3, and 6 months.
Conventional rTMS is applied to the left dorsolateral prefrontal cortex (DLPFC) using the standard 5 cm rule for scalp-based localization. Stimulation is delivered with intermittent theta-burst stimulation (iTBS) at 90% resting motor threshold (RMT), 3 pulses at 50 Hz per burst, repeated at 5 Hz, for a total of 1800 pulses per session. Each session lasts about 570 seconds. Participants complete 20 sessions over 4 weeks, with 2 sessions per day on 2 days per week.
Sham rTMS is delivered using a sham coil or low-intensity stimulation (10% RMT) to mimic the clicking sounds and scalp sensations of active rTMS without producing cortical activation. The sham sessions are matched to the active treatment in frequency, duration, and total number: 20 sessions in 4 weeks (2 sessions/day, 2 days/week, 570 seconds per session).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, 310015, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2025
First Posted
February 10, 2026
Study Start
February 1, 2026
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
February 10, 2026
Record last verified: 2026-01