Alcohol Use Disorder (AUD)NCT07755046
Repetitive Transcranial Magnetic Stimulation for Alcohol Use Disorder
A study testing Repetitive transcranial magnetic stimulation in people with Alcohol Use Disorder (AUD) and Alcoholism, run by Ting-Gang Chang at 1 site in Taiwan.
Trial summary
This study looked at whether repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation treatment, could help adults with alcohol use disorder when added to their usual treatment. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Alcohol Use Disorder (AUD), Alcoholism
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jun 2025to 14 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 20 to 65 years
- Diagnosis of alcohol use disorder according to DSM-5 criteria
- Able to provide written informed consent and complete study procedures
Who cannot join
- Moderate to severe alcohol withdrawal
- Psychiatric symptoms interfering with alcohol use disorder treatment
- Acute physical illness requiring hospitalization
- Standard contraindications to repetitive transcranial magnetic stimulation
- Pregnancy or planned pregnancy within one year
- Formal disability certification related to a psychiatric disorder
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taichung Veterans General Hospital, Taiwan
Taichung, Taiwan, 407219
About this study
Official title: Therapeutic Effects of Repetitive Transcranial Magnetic Stimulation on Alcohol Use Disorder: A One-Year, Randomized, Double-Blind MRI Tracking Study
This study looked at whether repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation treatment, could help adults with alcohol use disorder when added to their usual treatment. Nine adults receiving abstinence-oriented care received 10 sessions of stimulation over the right front part of the brain. Drinking severity, mood, craving and quality of life were assessed before treatment, immediately after the 10 sessions, and again at one and three months. Brain scans were also obtained at these visits to examine whether stimulation was associated with changes in brain connections. The study had no comparison group, so the results cannot show whether any change was caused by the stimulation.
Read the detailed description
This was a single-arm, open-label pilot study conducted at a single medical centre in Taiwan. Adults aged 20 to 65 years with DSM-5 alcohol use disorder were enrolled during inpatient or outpatient abstinence-oriented care, after the treating physician confirmed that acute withdrawal had stabilized.
Stimulation was delivered over the right dorsolateral prefrontal cortex at the F4 position using a Magstim Rapid2 system with a figure-of-eight D70 mm air film coil: 10 sessions at 10 Hz and 110% of the visually determined resting motor threshold, 60 trains of five seconds each, 3,000 pulses per session over approximately 30 minutes, delivered on consecutive weekdays. Concomitant pharmacological and psychosocial treatment continued as usual care and was not protocolized.
Assessments were conducted at baseline, after the tenth session, and at one and three months, and comprised clinical measures (Alcohol Use Disorders Identification Test, Patient Health Questionnaire-9, craving visual analogue scales, WHOQOL-BREF) and multimodal magnetic resonance imaging (resting-state functional MRI, diffusion tensor imaging and magnetic resonance spectroscopy).
The study was originally approved as a one-year, randomized, double-blind, sham-controlled trial with a larger planned sample. Funding constraints and difficulty recruiting this population prevented completion of that design, and the study was conducted as a single-arm, open-label pilot with follow-up to three months. The trial was registered retrospectively.
- Conditions
- Alcohol Use Disorder (AUD), Alcoholism
- Being tested
- Repetitive transcranial magnetic stimulation
- Keywords
- Repetitive transcranial magnetic stimulation, Dorsolateral prefrontal cortex, Alcohol Use Disorders Identification Test, Resting-state functional MRI, Diffusion tensor imaging, Magnetic resonance spectroscopy, Pilot study
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulationDevice
High-frequency repetitive transcranial magnetic stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Experimental | Ten sessions of active repetitive transcranial magnetic stimulation over the right dorsolateral prefrontal cortex (F4), at 10 Hz and 110% of the visually determined resting motor threshold, 60 trains of five seconds each, 3,000 pulses per session over approximately 30 minutes, delivered on consecutive weekdays. All participants received active stimulation in addition to usual abstinence-oriented care, which included pharmacological and psychosocial treatment that was not protocolized. Receives: Device: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Alcohol Use Disorders Identification Test (AUDIT) total score
AUDIT total score, range 0 to 40, with higher scores indicating more severe alcohol-related problems. Change from baseline was assessed at each follow-up.
Measured: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
Secondary outcomes (7)
Change in Patient Health Questionnaire-9 (PHQ-9) score
PHQ-9 total score, range 0 to 27, higher scores indicating more severe depressive symptoms.
Measured: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
Change in craving visual analogue scale score
Visual analogue scale, range 0 to 10, higher scores indicating stronger craving.
Measured: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
Change in WHOQOL-BREF total score
WHOQOL-BREF (Taiwan version) total score, higher scores indicating better quality of life.
Measured: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
Change in resting-state functional connectivity
Whole-brain and network-level functional connectivity derived from resting-state functional MRI using the Schaefer 100-parcel, seven-network atlas.
Measured: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
Change in white matter diffusion metrics
Fractional anisotropy and mean diffusivity derived from diffusion tensor imaging.
Measured: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
Change in brain metabolite concentrations
Metabolite concentrations measured by single-voxel magnetic resonance spectroscopy.
Measured: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
Adverse events
Adverse events elicited by open-ended enquiry at each stimulation session and imaging visit.
Measured: Throughout the stimulation course and follow-up, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start10 Jun 2025
- Primary completion14 Jun 2026
- Study completion14 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Model description
- Originally designed as a two-arm, randomized, double-blind, sham-controlled trial. Funding constraints and recruitment difficulty prevented completion of that design; all enrolled participants received active stimulation and the study was conducted as a single-arm, open-label pilot.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ting-Gang Chang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ting-Gang Chang, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755046
- Sponsor's protocol ID
- SF24002C
- Other IDs
- NSTC 113-2314-B-075A-006
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual-level data are not publicly available given the small sample and the potentially identifiable nature of the clinical data; de-identified data and analysis code may be made available by the corresponding author on reasonable request, subject to institutional review board approval.
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effects of Repetitive Transcranial Magnetic Stimulation on Alcohol Use Disorder: A One-Year, Randomized, Double-Blind MRI Tracking Study
- ClinicalTrials.gov ID
- NCT07755046
- Acronym / sponsor ID
- SF24002C
- Conditions
- Alcohol Use Disorder (AUD), Alcoholism
- Keywords
- Repetitive transcranial magnetic stimulation, Dorsolateral prefrontal cortex, Alcohol Use Disorders Identification Test, Resting-state functional MRI, Diffusion tensor imaging, Magnetic resonance spectroscopy, Pilot study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Ting-Gang ChangUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 14 Jun 2026 (actual)
- Study completion
- 14 Jun 2026 (actual)
- First posted
- 10 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study looked at whether repetitive transcranial magnetic stimulation (rTMS), a non-invasive brain stimulation treatment, could help adults with alcohol use disorder when added to their usual treatment. Nine adults receiving abstinence-oriented care received 10 sessions of stimulation over the right front part of the brain. Drinking severity, mood, craving and quality of life were assessed before treatment, immediately after the 10 sessions, and again at one and three months. Brain scans were also obtained at these visits to examine whether stimulation was associated with changes in brain connections. The study had no comparison group, so the results cannot show whether any change was caused by the stimulation.
Detailed description
This was a single-arm, open-label pilot study conducted at a single medical centre in Taiwan. Adults aged 20 to 65 years with DSM-5 alcohol use disorder were enrolled during inpatient or outpatient abstinence-oriented care, after the treating physician confirmed that acute withdrawal had stabilized.
Stimulation was delivered over the right dorsolateral prefrontal cortex at the F4 position using a Magstim Rapid2 system with a figure-of-eight D70 mm air film coil: 10 sessions at 10 Hz and 110% of the visually determined resting motor threshold, 60 trains of five seconds each, 3,000 pulses per session over approximately 30 minutes, delivered on consecutive weekdays. Concomitant pharmacological and psychosocial treatment continued as usual care and was not protocolized.
Assessments were conducted at baseline, after the tenth session, and at one and three months, and comprised clinical measures (Alcohol Use Disorders Identification Test, Patient Health Questionnaire-9, craving visual analogue scales, WHOQOL-BREF) and multimodal magnetic resonance imaging (resting-state functional MRI, diffusion tensor imaging and magnetic resonance spectroscopy).
The study was originally approved as a one-year, randomized, double-blind, sham-controlled trial with a larger planned sample. Funding constraints and difficulty recruiting this population prevented completion of that design, and the study was conducted as a single-arm, open-label pilot with follow-up to three months. The trial was registered retrospectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Originally designed as a two-arm, randomized, double-blind, sham-controlled trial. Funding constraints and recruitment difficulty prevented completion of that design; all enrolled participants received active stimulation and the study was conducted as a single-arm, open-label pilot.
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: Repetitive transcranial magnetic stimulationTen sessions of active repetitive transcranial magnetic stimulation over the right dorsolateral prefrontal cortex (F4), at 10 Hz and 110% of the visually determined resting motor threshold, 60 trains of five seconds each, 3,000 pulses per session over approximately 30 minutes, delivered on consecutive weekdays. All participants received active stimulation in addition to usual abstinence-oriented care, which included pharmacological and psychosocial treatment that was not protocolized. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 20 to 65 years
- Diagnosis of alcohol use disorder according to DSM-5 criteria
- Able to provide written informed consent and complete study procedures
Key exclusion criteria (6 listed)
- Moderate to severe alcohol withdrawal
- Psychiatric symptoms interfering with alcohol use disorder treatment
- Acute physical illness requiring hospitalization
- Standard contraindications to repetitive transcranial magnetic stimulation
- Pregnancy or planned pregnancy within one year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transcranial magnetic stimulationHigh-frequency repetitive transcranial magnetic stimulation | Device | Active rTMS |
Primary outcome
Change in Alcohol Use Disorders Identification Test (AUDIT) total score
Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
AUDIT total score, range 0 to 40, with higher scores indicating more severe alcohol-related problems. Change from baseline was assessed at each follow-up.
7 secondary outcomes
Change in Patient Health Questionnaire-9 (PHQ-9) score
Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
Change in craving visual analogue scale score
Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
Change in WHOQOL-BREF total score
Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
Change in resting-state functional connectivity
Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
Change in white matter diffusion metrics
Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
Change in brain metabolite concentrations
Time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months
Adverse events
Time frame: Throughout the stimulation course and follow-up, up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No. Individual-level data are not publicly available given the small sample and the potentially identifiable nature of the clinical data; de-identified data and analysis code may be made available by the corresponding author on reasonable request, subject to institutional review board approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Alcohol Use Disorder (AUD) and Alcoholism, run by Ting-Gang Chang at 1 site in Taiwan.
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 3 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: finished, as of the sponsor's last update on 10 Aug 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 Taiwan. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Alcohol Use Disorders Identification Test (AUDIT) total score (time frame: Baseline, after the tenth stimulation session (median 2 days), 1 month, and 3 months). 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 Aug 2026.