This study aims to evaluate the efficacy of transcranial ultrasound stimulation in reducing cravings and preventing relapse in individuals with alcohol use disorders. Utilizing a double-blind design, participants will be randomly assigned to receive either active accelerated transcranial ultrasound stimulation or a sham treatment.
As a major global public health issue, the core therapeutic goal of alcohol use disorder (AUD) is to reduce alcohol craving and prevent relapse. In recent years, transcranial ultrasound stimulation (TUS) has emerged as a reliable non-invasive neuromodulation technique. Studies have shown that abnormalities in neural activity and structure in the ventromedial prefrontal cortex (vmPFC) of AUD are closely associated with alcohol craving and dysregulation of the reward system. However, existing research on non-invasive neuromodulation techniques for AUD has primarily focused on other brain regions, with limited exploration of interventions targeting the vmPFC. This study aims to evaluate the efficacy of a TUS intervention targeting the vmPFC through a randomized controlled trial, assessing its potential to reduce alcohol craving and prevent relapse, thereby providing a theoretical foundation for clinical translation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
The sham stimulation protocol maintained identical parameter settings to the active treatment group with equivalent application of ultrasound coupling gel at the left vmPFC site localized via the FP1 electrode. Crucially, the ultrasound transducer's output trigger was disabled during sham sessions, ensuring identical device operation procedures without acoustic energy delivery. Participants received daily 15-minute sham sessions matching the active group's 10-day treatment schedule.
Participants in the active stimulation group will receive the transcranial ultrasound stimulation (TUS) targeted the left ventromededial prefrontal cortex (vmPFC), localized via the FP1 electrode position of the International 10-20 EEG system. The TUS will be delivered in the form of pulsed sinusoidal waves, with a fundamental frequency of 0.5 MHz and an intensity of 8 W/cm² (spatial peak pulse average intensity \[Isppa\]). The pulse duration will be 500 microseconds, and the sonication bursts will consist of 50 tone bursts per session, with a duty cycle of 5%. Each burst (pulse repetition frequency: 100 Hz) was followed by an 8-second inter-burst interval, yielding a total session duration of 15 minutes. Participants underwent one daily session for 10 consecutive days.
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
The change of alcohol craving
Alcohol craving was assessed using the Visual Analog Scale (VAS; 0-10 points, higher scores indicating greater craving) during dual-condition olfactory exposure. Participants completed sequential 1.5-minute sniffing trials with alcohol cues and neutral stimuli (water), with the final craving score calculated as the alcohol-induced VAS score minus the neutral-state baseline.
Time frame: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
The change of relapse behaviors with alcohol
Alcohol consumption and related behaviors were assessed using the Alcohol Use Disorders Identification Test (AUDIT,10 item). Each item is scored from 0 to 4 points, with higher scores indicating greater alcohol consumption.
Time frame: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
The change of drinking symptom
Drinking symptom will be measured by Obsessive Compulsive Drinking Scale (OCDS), a 14-item scale assessing obsessive and compulsive drinking behaviors. Each item is scored from 0 to 4 points. The total score of OCDS ranged from 0 to 56.
Time frame: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
The change of sleep
Sleep will be measured by the Pittsburgh Sleep Quality Index (PSQI) rated by both patients and observers. The total score of PSQI ranged from 0 to 21, in which higher scores mean a lower level of sleep quality.
Time frame: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
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The change of depression
A provider administered questionnaire used to assess remission from depression. The HAMD-17 is a 17-item questionnaire to assess depression severity. Each item is scored from 0-4, with higher scores representing increasing depression severity.
Time frame: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
The change of anxiety
The HAMD-14 is a 14-item questionnaire to assess depression severity. Each item is scored from 0-4, with higher scores representing increasing anxiety severity.
Time frame: baseline, immediately after the intervention, two weeks after the intervention, one month after the intervention, two months after the intervention, three months after the intervention
The change of self-control
The change of self-control will be measured by the stop-signal task and monetary incentive delay task.
Time frame: baseline, immediately after the intervention.