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NCT Number: NCT07472673

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

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.

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Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. 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

  1. Number of participants who relapse

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

    Follow up with patients after discharge, evaluate number of participants who relapse.

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

    Time frame: Baseline and 7 days after intervention

    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.

  3. Anxiety status assessed by Generalized Anxiety Disorder-7(GAD-7)

    Time frame: Baseline and 7 days after intervention

    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.

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

    Time frame: Baseline and 7 days after intervention

    assessed by the natural reward/alcohol choice preference paradigm under simultaneous electroencephalogram and electrocardiogram recording.

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

    Time frame: Baseline and 7 days after intervention

    assessed by the negative reward prediction error E-prime paradigm under simultaneous electroencephalogram and electrocardiogram recording.

  6. Emotional states assessed using the Depression Anxiety Stress Scales (DASS).

    Time frame: Baseline and 7 days after intervention

    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.

  7. levels of positive and negative affect assessed by Positive and Negative Affect Schedule (PANAS)

    Time frame: Baseline and 7 days after intervention

    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.

  8. perceived stress assessed by Perceived Stress Scale (PSS)

    Time frame: Baseline and 7 days after intervention

    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.

  9. Functional connectivity assessed by MRI

    Time frame: Baseline and 7 days after intervention

    evaluate all participants' functional connectivity in the brain by MRI

  10. Cognitive emotion regulation strategies assessed by Cognitive Emotion Regulation Questionnaire (CERQ）

    Time frame: Baseline and 7 days after intervention

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tianzhen Chen, M.D, Ph.D

CONTACT

[email protected]

021-34773523

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 16, 2026
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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