Alcohol Use DisorderNCT07472673
Transcranial Temporal Interference Stimulation Targeted of the Amygdala as an Intervention for Alcohol Use Disorder Patients
A study testing tTIS on Amygdala, 10 Hz in people with Alcohol Use Disorder, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The purpose of this research is to investigate the efficacy of transcranial temporal interference stimulation (tTIS) targeting the amygdala in patients with alcohol use disorder. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- tTIS on Amygdala, 10 Hz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2026to 31 Dec 2026
- 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 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- aged 18 to 60 years old;
- Meets the DSM-5 diagnostic criteria for alcohol use disorder;
- Normal or corrected normal vision and hearing;
- Able to cooperate in completing the questionnaire assessment and behavioral tests;
- No metal implantation in the head, no history of neurological problems or head injury.
Who cannot join
- Suffering from severe cognitive dysfunction, such as a history of head trauma, cerebrovascular disease, epilepsy, etc., use of cognitive-promoting medications in the last 6 months;
- serious physical or neurological illness, a diagnosis of any other psychiatric disorder under DSM-5 criteria (except for nicotine use disorder); Other psychoactive substance abuse or dependence in the last 5 years (except nicotine).
- any contraindications to transcranial electrical stimulation.
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
Shanghai Mental Health Center
Shanghai, 200000
Min Zhao, M.D, Ph.D, 18017311005, drminzhao@smhc.org.cn
About this study
Official title: Exploring the Efficacy and Neural Mechanisms of Transcranial Temporal Interference Stimulation Modulating the Amygdala on Patients With Alcohol Use Disorder
The purpose of this research is to investigate the efficacy of transcranial temporal interference stimulation (tTIS) targeting the amygdala in patients with alcohol use disorder.
Read the detailed description
This study employs a randomized, double-blind design to investigate the emerging non-invasive deep brain stimulation modality of temporal interference stimulation (tTIS) targeted at the amygdala, aiming to validate the efficacy and feasibility of non-invasively modulating the amygdala for the treatment of patients with alcohol use disorder (AUD). During the intervention phase, all participants will be randomly assigned to receive either active stimulation or sham stimulation. The localization of the amygdala will be modeled based on individual brain imaging data for each participant. Clinical characteristics, electroencephalography (EEG) and magnetic resonance imaging (MRI) data will be collected from all patients at baseline and post-intervention. In addition, follow-up assessments of alcohol consumption will be conducted for all participants after the intervention.
- Conditions
- Alcohol Use Disorder
- Being tested
- tTIS on Amygdala, 10 Hz, tTIS on Amygdala, Sham
- Keywords
- Alcohol use disorder
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tTIS on Amygdala, 10 HzDevice
Through the transcranial electric stimulation device, the first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2.010 kHz. According to the principle of time-domain coherence, an alternating electric field with a frequency of f2-f1 = 10 Hz can be generated in the target area. The optimal electrode position and current parameters are determined by using the individualized modeling. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol.
tTIS on Amygdala, ShamDevice
The first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2 kHz. The optimal electrode position and current parameters are determined by using the individualized modeling. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol.
| Study group | Role | What they receive |
|---|---|---|
| tTIS stimulation group | Experimental | The two high-frequency electric fields of the temporal interference (TI) device are set at distinct frequencies (2 kHz and 2.010 kHz), thereby generating a low-frequency electric field (10 Hz) specifically targeted at the amygdala.
For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol. The intervention lasted for one week, administered twice session daily for 30 minutes per session. Receives: Device: tTIS on Amygdala, 10 Hz |
| Sham tTIS stimulation group | Sham comparator | The two high-frequency electric fields of the temporal interference (TI) device are set at the same frequencies (2 kHz and 2 kHz), which are specifically targeted at the amygdala. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol. The intervention lasted for one week, administered twice session daily for 30 minutes per session. Receives: Device: tTIS on Amygdala, Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Craving assessed by Visual Analog Scale
evaluate all participants' craving for for alcohol assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 100, and higher values represent high level of craving.
Measured: Reported by participants before and after intervention, as well as during the 1 and 4 weeks follow-up period.
Secondary outcomes (10)
Number of participants who relapse
Follow up with patients after discharge, evaluate number of participants who relapse.
Measured: At 1 week, 2 weeks, and 4 weeks after participants' discharge from the hospital.
Depression status assessed by Patient Health Questionnaire-9(PHQ-9)
evaluate all participants' depression status by Patient Health Questionnaire-9(PHQ-9), PHQ-9 range from 0 to 27, and higher values represent more severe level of depression.
Measured: Baseline and 7 days after intervention
Anxiety status assessed by Generalized Anxiety Disorder-7(GAD-7)
evaluate all participants' anxiety status by Generalized Anxiety Disorder Screener (GAD-7). GAD-7 range from 0 to 21, and higher values represent more severe level of anxiety.
Measured: Baseline and 7 days after intervention
Preference in natural/alcohol rewards assessed by a reward/alcohol choice preference E-prime paradigm
assessed by the natural reward/alcohol choice preference paradigm under simultaneous electroencephalogram and electrocardiogram recording.
Measured: Baseline and 7 days after intervention
Responses to negative reward prediction error assessed by a negative reward prediction error E-prime paradigm
assessed by the negative reward prediction error E-prime paradigm under simultaneous electroencephalogram and electrocardiogram recording.
Measured: Baseline and 7 days after intervention
Emotional states assessed using the Depression Anxiety Stress Scales (DASS).
Depression, anxiety and stress levels of all participants were assessed using the Depression Anxiety Stress Scales (DASS). Scores on the DASS ranged from 0 to 63, with higher scores indicating more severe levels of depression, anxiety and stress.
Measured: Baseline and 7 days after intervention
levels of positive and negative affect assessed by Positive and Negative Affect Schedule (PANAS)
evaluate all participants' levels of positive and negative affect by Positive and Negative Affect Schedule (PANAS).The PANAS consists of two dimensions: positive affect and negative affect, with scores ranging from 10 to 50 for each dimension, with higher scores indicating stronger positive or negative affect.
Measured: Baseline and 7 days after intervention
perceived stress assessed by Perceived Stress Scale (PSS)
evaluate all participants' the level of perceived stress by the Perceived Stress Scale (PSS). PSS range from 0 to 40, and higher values represent higher level of perceived stress.
Measured: Baseline and 7 days after intervention
Functional connectivity assessed by MRI
evaluate all participants' functional connectivity in the brain by MRI
Measured: Baseline and 7 days after intervention
Cognitive emotion regulation strategies assessed by Cognitive Emotion Regulation Questionnaire (CERQ）
evaluate all participants' the Cognitive emotion regulation strategies by the Cognitive Emotion Regulation Questionnaire (CERQ). The CERQ consists of four subscales, with scores for each subscale ranging from 4 to 20. Higher scores indicate more frequent use of the corresponding cognitive emotion regulation strategy.
Measured: Baseline and 7 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start15 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Min Zhao, M.D, Ph.D, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07472673
- Sponsor's protocol ID
- MZhao-026
- Other IDs
- 2021ZD0202105, 82571704
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There are no plans to share de-identified individual participant data (IPD) collected in this study with other researchers outside the primary research group. The decision not to share IPD is mainly based on protecting the privacy and confidentiality of individual participants, as well as complying with relevant ethical review requirements and data protection regulations. All data collected in this study will only be used for the analysis and reporting of this study to ensure the security and compliance of participant information.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Efficacy and Neural Mechanisms of Transcranial Temporal Interference Stimulation Modulating the Amygdala on Patients With Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT07472673
- Acronym / sponsor ID
- MZhao-026
- Conditions
- Alcohol Use Disorder
- Keywords
- Alcohol use disorder
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Mar 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.
The purpose of this research is to investigate the efficacy of transcranial temporal interference stimulation (tTIS) targeting the amygdala in patients with alcohol use disorder.
Detailed description
This study employs a randomized, double-blind design to investigate the emerging non-invasive deep brain stimulation modality of temporal interference stimulation (tTIS) targeted at the amygdala, aiming to validate the efficacy and feasibility of non-invasively modulating the amygdala for the treatment of patients with alcohol use disorder (AUD). During the intervention phase, all participants will be randomly assigned to receive either active stimulation or sham stimulation. The localization of the amygdala will be modeled based on individual brain imaging data for each participant. Clinical characteristics, electroencephalography (EEG) and magnetic resonance imaging (MRI) data will be collected from all patients at baseline and post-intervention. In addition, follow-up assessments of alcohol consumption will be conducted for all participants after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tTIS stimulation group | Experimental | Device: tTIS on Amygdala, 10 HzThe two high-frequency electric fields of the temporal interference (TI) device are set at distinct frequencies (2 kHz and 2.010 kHz), thereby generating a low-frequency electric field (10 Hz) specifically targeted at the amygdala. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol. The intervention lasted for one week, administered twice session daily for 30 minutes per session. |
| Sham tTIS stimulation group | Sham comparator | Device: tTIS on Amygdala, ShamThe two high-frequency electric fields of the temporal interference (TI) device are set at the same frequencies (2 kHz and 2 kHz), which are specifically targeted at the amygdala. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol. The intervention lasted for one week, administered twice session daily for 30 minutes per session. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- aged 18 to 60 years old;
- Meets the DSM-5 diagnostic criteria for alcohol use disorder;
- Normal or corrected normal vision and hearing;
- Able to cooperate in completing the questionnaire assessment and behavioral tests;
- No metal implantation in the head, no history of neurological problems or head injury.
Key exclusion criteria (3 listed)
- Suffering from severe cognitive dysfunction, such as a history of head trauma, cerebrovascular disease, epilepsy, etc., use of cognitive-promoting medications in the last 6 months;
- serious physical or neurological illness, a diagnosis of any other psychiatric disorder under DSM-5 criteria (except for nicotine use disorder); Other psychoactive substance abuse or dependence in the last 5 years (except nicotine).
- any contraindications to transcranial electrical stimulation.
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 |
|---|---|---|
| tTIS on Amygdala, 10 HzThrough the transcranial electric stimulation device, the first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2.010 kHz. According to the principle of time-domain coherence, an alternating electric field with a frequency of f2-f1 = 10 Hz can be generated in the target area. The optimal electrode position and current parameters are determined by using the individualized modeling. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol. | Device | tTIS stimulation group |
| tTIS on Amygdala, ShamThe first pair of electrodes continuously outputs a current with a frequency of f1 = 2 kHz, while the second pair continuously outputs a current with a frequency of f2 = 2 kHz. The optimal electrode position and current parameters are determined by using the individualized modeling. For each participant, the current intensity was determined via electric field simulation to implement an individualized intervention protocol. | Device | Sham tTIS stimulation group |
Primary outcome
Change of Craving assessed by Visual Analog Scale
Time frame: Reported by participants before and after intervention, as well as during the 1 and 4 weeks follow-up period.
evaluate all participants' craving for for alcohol assessed by Visual Analog Scales (VAS). Score of VAS range from 0 to 100, and higher values represent high level of craving.
10 secondary outcomes
Number of participants who relapse
Time frame: At 1 week, 2 weeks, and 4 weeks after participants' discharge from the hospital.
Depression status assessed by Patient Health Questionnaire-9(PHQ-9)
Time frame: Baseline and 7 days after intervention
Anxiety status assessed by Generalized Anxiety Disorder-7(GAD-7)
Time frame: Baseline and 7 days after intervention
Preference in natural/alcohol rewards assessed by a reward/alcohol choice preference E-prime paradigm
Time frame: Baseline and 7 days after intervention
Responses to negative reward prediction error assessed by a negative reward prediction error E-prime paradigm
Time frame: Baseline and 7 days after intervention
Emotional states assessed using the Depression Anxiety Stress Scales (DASS).
Time frame: Baseline and 7 days after intervention
levels of positive and negative affect assessed by Positive and Negative Affect Schedule (PANAS)
Time frame: Baseline and 7 days after intervention
perceived stress assessed by Perceived Stress Scale (PSS)
Time frame: Baseline and 7 days after intervention
Functional connectivity assessed by MRI
Time frame: Baseline and 7 days after intervention
Cognitive emotion regulation strategies assessed by Cognitive Emotion Regulation Questionnaire (CERQ）
Time frame: Baseline and 7 days after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Individual participant dataSharing planned: No. There are no plans to share de-identified individual participant data (IPD) collected in this study with other researchers outside the primary research group. The decision not to share IPD is mainly based on protecting the privacy and confidentiality of individual participants, as well as complying with relevant ethical review requirements and data protection regulations. All data collected in this study will only be used for the analysis and reporting of this study to ensure the security and compliance of participant information.
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
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.
Min Zhao, M.D, Ph.D principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tTIS on Amygdala, 10 Hz in people with Alcohol Use Disorder, run by Shanghai Mental Health Center 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 3 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 16 Mar 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 Tianzhen Chen, M.D, Ph.D (021-34773523, vomchan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Craving assessed by Visual Analog Scale (time frame: Reported by participants before and after intervention, as well as during the 1 and 4 weeks follow-up period.). 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 16 Mar 2026.