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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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.
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.
Shanghai Mental Health Center
Shanghai, China
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.
Time frame: Reported by participants before and after intervention, as well as during the 1 and 4 weeks follow-up period.
Number of participants who relapse
Follow up with patients after discharge, evaluate 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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 7 days after intervention
Functional connectivity assessed by MRI
evaluate all participants' functional connectivity in the brain by MRI
Time frame: 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.
Time frame: Baseline and 7 days after intervention