---
title: Transcranial Temporal Interference Stimulation Targeted of the Amygdala as an Intervention for Alcohol Use Disorder Patients
nct_id: NCT07472673
overall_status: NOT_YET_RECRUITING
phase: NA
sponsor: Shanghai Mental Health Center
study_type: INTERVENTIONAL
primary_condition: Alcohol Use Disorder
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07472673.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07472673"
ct_last_update_post_date: 2026-03-16
last_seen_at: "2026-05-12T06:19:25.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Transcranial Temporal Interference Stimulation Targeted of the Amygdala as an Intervention for Alcohol Use Disorder Patients

**Official Title:** Exploring the Efficacy and Neural Mechanisms of Transcranial Temporal Interference Stimulation Modulating the Amygdala on Patients With Alcohol Use Disorder

**NCT ID:** [NCT07472673](https://clinicaltrials.gov/study/NCT07472673)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** Shanghai Mental Health Center
- **Conditions:** Alcohol Use Disorder
- **Start Date:** 2026-02-15
- **Completion Date:** 2026-12-31
- **CT.gov Last Update:** 2026-03-16

## 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 60 Years
- **Sex:** MALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
```

## Arms

- **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.
- **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.

## 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 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.

## Primary Outcomes

- **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.

## 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)_

## Locations (1)

- Shanghai Mental Health Center, Shanghai, China

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.shanghai mental health center|shanghai||china` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT07472673.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT07472673*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*