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| ID | Type | Description | Link |
|---|---|---|---|
| 2021ZD0202105 | Other Grant/Funding Number | STI 2030 Initiative - Brain Science and Brain-Inspired Research | |
| 82571704 | Other Grant/Funding Number | National Natural Science Foundation of China (NSFC) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants who relapse | Follow up with patients after discharge, evaluate 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianzhen Chen, M.D, Ph.D | Contact | 021-34773523 | vomchan@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Min Zhao, M.D, Ph.D | Shanghai Mental Health Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Mental Health Center | Shanghai | 200000 | China |
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.
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| 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. |
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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. |
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline and 7 days after intervention |
| Functional connectivity assessed by MRI | evaluate all participants' functional connectivity in the brain by MRI | 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. | Baseline and 7 days after intervention |