Transcranial Temporal Interference Stimulation Targeted of the Amygdala as an Intervention for Alcohol Use Disorder Patients

NCT07472673 | Not Yet Recruiting

• 3 other identifiers: MZhao-0262021ZD020210582571704
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder

Keywords

Alcohol use disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  At 1 week, 2 weeks, and 4 weeks after participants' discharge from the hospital.

• Depression status assessed by Patient Health Questionnaire-9(PHQ-9)

  Baseline and 7 days after intervention

• Anxiety status assessed by Generalized Anxiety Disorder-7(GAD-7)

  Baseline and 7 days after intervention

• Preference in natural/alcohol rewards assessed by a reward/alcohol choice preference E-prime paradigm

  Baseline and 7 days after intervention

• Responses to negative reward prediction error assessed by a negative reward prediction error E-prime paradigm

  Baseline and 7 days after intervention

Study Arms (2)

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.

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.

Device: tTIS on Amygdala, Sham

Interventions

tTIS on Amygdala, 10 Hz DEVICE

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 stimulation group

tTIS on Amygdala, Sham 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 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.

Sham tTIS stimulation group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, 200000, China

Location

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Min Zhao, M.D, Ph.D

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tianzhen Chen, M.D, Ph.D

CONTACT

021-34773523; vomchan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 16, 2026
• Study Start: February 15, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)