This study aims to systematically explore the effectiveness of accelerated HD-tACS in treating AUD, particularly its efficacy in reducing alcohol craving and preventing relapse in AUD patients.
This study conducted a multi-center randomized clinical controlled trial among individuals with alcohol use disorders, aiming to verify the effectiveness of accelerated HD-tACS in targeting the dorsolateral prefrontal cortex for the treatment of AUD. In particular, it aimed to assess the efficacy of accelerated HD-tACS in reducing alcohol craving and reducing relapse. Eligible patients were randomly divided into the accelerated HD-tACS group and the sham stimulation group in a 1:1 ratio. Clinical and electroencephalogram data were collected at baseline and after the intervention. Additionally, a follow-up assessment of alcohol consumption was conducted for all participants after the intervention ended.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
The stimulation parameters are 40Hz and 2mA. The stimulation protocol is 20 minutes per session, 3 times per day, for a total of 10 consecutive days.
The stimulation parameters are 40Hz and 2mA. The stimulation protocol is 20 minutes per session, 3 times per day, for a total of 10 consecutive days. At the commencement and conclusion of each therapeutic session, a 30-second ramp-up stimulation and a 30-second ramp-down stimulation (totaling 60 seconds) are administered, respectively, while the current output of the device is maintained at zero throughout the intervening interval.
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
Change of Craving
Visual Analog Scale, range 0-100 point, the higher the score, the more one wants drugs.
Time frame: baseline; The 2nd, 4th, 6th, 8th and 10th days during the intervention period; 4 weeks after treatment; 12 weeks after treatment
impulsivity
Stop Single Task
Time frame: baseline; 1 day after the treatment was completed
Negative reinforcement learning task
The negative reinforcement learning task was adopted to evaluate the patients' avoidance-avoidance behaviors and learning. By calculating and modeling, the avoidance-avoidance behavior bias (active avoidance bias ) and the learning rates based on different feedback: learning from successfully avoiding the aversive stimulus; learning from experiencing the aversive stimulus) were constructed.
Time frame: baseline; 1 day after treatment was completed
Changes in Reward Learning
Reward Learning Task
Time frame: baseline; 1 day after treatment was completed
Compulsory drinking
The Obsessive Compulsive Drinking Scale (OCDS) assesses compulsive thoughts and impulsive behaviors related to alcohol consumption. It consists of 14 items, each rated on a 5-point scale from 0 to 4. Scores ranging from 0 to 14 indicate almost no compulsive drinking characteristics, 15 to 28 indicate obvious compulsive thoughts or impulses, and scores above 29 indicate a significant compulsive drinking pattern with a high risk of relapse.
Time frame: baseline; 1 day after treatment was completed
Depressive state
The depression assessment was conducted using the Patient Health Questionnaire - 9 (PHQ-9), which consists of 9 items, each representing a different aspect of depressive symptoms. Each item is scored on a 4-point scale. 0-4 points indicate no depressive symptoms, 5-9 points represent mild depression, 10-14 points indicate moderate depression, and scores above 15 indicate severe depression.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: baseline; 1 day after treatment was completed
Anxiety state
The anxiety assessment was conducted using the Generalized Anxiety Disorder - 7 (GAD-7) self-rating scale. The core statistical indicator of this scale is the total score. The higher the score, the more severe the anxiety. A total score of 0-4 indicates no anxiety or the anxiety level is not clinically significant; a score of 5-9 represents mild anxiety; a score of 10-14 indicates moderate anxiety; and a score of 15 or above indicates severe anxiety.
Time frame: baseline; 1 day after treatment was completed;
Sleeping conditions
The assessment was conducted using the Pittsburgh Sleep Quality Index (PSQI), with the total score ranging from 0 to 21. A higher score indicates poorer sleep quality.
Time frame: baseline; 1 day after the treatment was completed
EEG
EEG features such as event-related potentials (ERPs) and power spectral density (e.g., theta or alpha power)
Time frame: baseline; 1 day after treatment was completed
EEG
change of functional connection of brain area
Time frame: baseline; 1 day after treatment was completed
use of alcohol
Simple questionnaire to collect alcohol consumption and drinking frequency.
Time frame: 4 weeks after treatment; 12 weeks after treatment