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Liver Diseases, AlcoholicP-TMS MetALDNCT07399600

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

A study testing Individually Targeted rTMS and Conventional rTMS in people with Liver Diseases, Alcoholic and Fatty Liver, run by The Affiliated Hospital of Hangzhou Normal University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Individually Targeted rTMS and Conventional rTMS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
105 participants
Where
1 siteChina
Study dates
1 Feb 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • The Affiliated Hospital of Hangzhou Normal University

    Hangzhou, Zhejiang, 310015

    junping shi, 86+13957121199, 20131004@hznu.edu.cn

Other trials in China

About this study

Official title: Personalized Transcranial Magnetic Stimulation for Metabolic Dysfunction and Alcohol-Related Liver Disease (MetALD): A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

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?
Read more

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.
Being tested
Individually Targeted rTMS, Conventional rTMS, Transcranial Magnetic Stimulation Sham
Keywords
Liver Diseases, Alcoholic, Fatty Liver, Metabolic Syndrome, Transcranial Magnetic Stimulation, Randomized Controlled Trial
Medical subject headings
Liver Diseases, Alcoholic, Fatty Liver, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individually Targeted rTMSDevice

    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 rTMSDevice

    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.

  • Transcranial Magnetic Stimulation ShamDevice

    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).

Study groups in NCT07399600
Study groupRoleWhat they receive
Conventional rTMSActive comparatorNot described
Receives: Device: Conventional rTMS
Sham rTMSSham comparatorNot described
Receives: Device: Transcranial Magnetic Stimulation Sham
Active rTMSExperimentalNot described
Receives: Device: Individually Targeted rTMS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: From baseline to the end of treatment (Week 4)

Secondary outcomes (29)
  1. Change in Controlled Attenuation Parameter (CAP, dB/m) From Baseline as Assessed by Vibration-Controlled Transient Elastography (FibroScan® VCTE)

    Measured: From baseline to mid-treatment (Week 2), end of treatment (Week 4), and at 1-, 3-, and 6-month follow-up

  2. Change in Liver Stiffness Measurement (LSM, kPa) From Baseline as Assessed by FibroScan® VCTE

    Measured: From baseline to mid-treatment (Week 2), end of treatment (Week 4), and at 1-, 3-, and 6-month follow-up

  3. LFC From Baseline as Measured by MRI-PDFF

    Measured: From baseline to the end of treatment (Week 4)

  4. Proportion of Participants Achieving ≥30% or ≥50% Reduction in LFC From Baseline

    Measured: From baseline to the end of treatment (Week 4)

  5. Change in Serum Levels of Liver Enzymes (ALT, AST, ALP, GGT [U/L]) From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  6. Change in Serum Level of Albumin From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  7. Change in International Normalized Ratio (INR) From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  8. Change in Prothrombin Time (PT) From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  9. Change in Serum Level of Total Bilirubin (TBIL) From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  10. Proportion of Participants With ALT Reduction >17 U/L From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  11. Change in Glucose Metabolism Markers (HOMA-IR [Index]; HOMA-β [Index]) From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  12. Change in Glucose Metabolism Markers (HbA1c [%]) From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  13. Change in Fasting Plasma Glucose (FPG) From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  14. Change in Fasting Insulin From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  15. Change in Concentration of Conventional Lipid Panel (TC, TG, HDL-C, LDL-C, non-HDL-C, VLDL-C [mmol/L]) From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  16. Change in Concentration of Apolipoproteins (Apo A1, Apo B [g/L]) From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  17. Change in Serum Lipoprotein(a) (Lp(a)) Concentration From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  18. Change in Serum Free Fatty Acids (FFA) Concentration From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  19. Change in Body Weight [kg] From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  20. Change in BMI [kg/m²] From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  21. Change in Body Circumferences (Waist, Hip) [cm] From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  22. Change in Waist-to-Hip Ratio From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  23. Change in General Food Craving Questionnaire-Trait (G-FCQ-T) Total Score From Baseline

    G-FCQ-T The General Food Craving Questionnaire-Trait (G-FCQ-T) is a self-reported instrument used to assess the general tendency to experience food cravings. It comprises 21 items. Participants rate each item on a 6-point Likert scale ranging from 1 ("Never") to 6 ("Always"). The total score is the sum of all item ratings, with a possible range from 21 to 126. A higher total score indicates a more severe trait propensity for food craving.

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  24. Change in General Food Craving Questionnaire-State (G-FCQ-S) Total Score From Baseline

    G-FCQ-S The General Food Craving Questionnaire-State (G-FCQ-S) is a self-reported instrument used to assess the current, momentary state of food craving. It comprises 15 items. Participants rate each item on a 6-point Likert scale ranging from 1 ("Strongly Disagree") to 6 ("Strongly Agree"). The total score is the sum of all item ratings, with a possible range from 15 to 90. A higher total score indicates a more intense current state of food craving.

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  25. Change in Score on Visual Analogue Scale (VAS) for Subjective Food Craving From Baseline

    Subjective food craving is assessed using a Visual Analogue Scale (VAS). Participants indicate their current, momentary level of food craving by marking a point on a 100-mm horizontal line. The left endpoint (0 mm) is labeled "No food craving at all," and the right endpoint (100 mm) is labeled "The most intense food craving imaginable." The score is determined by measuring the distance from the left endpoint to the participant's mark, ranging from 0 to 100. A higher score indicates a more intense subjective feeling of food craving.

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  26. Change in Caloric intake recorded by the Mint Health App From Baseline

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  27. Change in Alcohol Use Disorders Identification Test (AUDIT) Score From Baseline

    The Alcohol Use Disorders Identification Test (AUDIT) is a simple, self-reported screening tool developed by the World Health Organization (WHO) to identify hazardous and harmful patterns of alcohol consumption. The questionnaire consists of 10 items. The first 8 items are scored on a scale from 0 to 4. Items 9 and 10 are scored 0, 2, or 4. The total score is the sum of all item ratings, with a possible range from 0 to 40. A higher total score indicates a greater likelihood of hazardous and harmful alcohol use, as well as possible alcohol dependence.

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  28. Change in Penn Alcohol Craving Scale (PACS) Score From Baseline

    The Penn Alcohol Craving Scale (PACS) is a self-reported questionnaire designed to measure the intensity of an individual's craving for alcohol over the past week. The scale consists of 5 items assessing the frequency, duration, and intensity of craving, the ability to resist drinking, and the overall rating of craving. Each item is rated on a 6-point scale from 0 to 6, with varying verbal anchors for each item (e.g., "Never" to "Nearly All the Time"). The total score is the sum of all 5 item ratings, with a possible range from 0 to 30. A higher total score indicates a more severe level of subjective alcohol craving.

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

  29. Change in Alcohol Consumption Assessed by the Timeline Followback (TLFB) Method From Baseline

    Alcohol consumption is assessed using the Timeline Followback (TLFB) method, a structured interview that provides a quantitative estimate of an individual's daily drinking. Using a calendar to aid recall, participants retrospectively report their daily alcohol consumption over a specified period (e.g., the past 30 days). The data is used to calculate key metrics such as the number of drinking days, the number of heavy drinking days, and the average number of standard drinks consumed per day or per week. A higher value indicates a greater level of alcohol consumption.

    Measured: baseline, mid-treatment (Week 2), end of treatment (Week 4), 1, 3, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start1 Feb 2026 (estimated)
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
105 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07399600
Sponsor's protocol ID
SJP20250926
Acronym
P-TMS MetALD
Status last verified
Jan 2026
First submitted
17 Nov 2025
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Individually Targeted rTMS and Conventional rTMS in people with Liver Diseases, Alcoholic and Fatty Liver, run by The Affiliated Hospital of Hangzhou Normal University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Junping Shi (+86 13957121199, 20131004@hznu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: From baseline to the end of treatment (Week 4)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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