Clinical trial NCT06867224: Transcranial Ultrasound Stimulation As a Neuromodulation Therapy for Craving and Relapse Behaviors in Alcohol Use Disorder.
Official title: Transcranial Ultrasound Stimulation As a Neuromodulation Therapy for Craving and Relapse Behaviors in Alcohol Use Disorder.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder (AUD)
Transcranial Ultrasound Stimulation
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Education level of junior high school or above, capable of completing questionnaires and behavioral tests;
* Aged 18-60 years;
* Meet DSM-5 diagnostic criteria for Alcohol Use Disorder;
* No abnormal findings on physical examination;
* Agree to participate in follow-up assessments;
* No contraindications for MRI scanning.

Exclusion criteria:

* Have impaired intelligence (Intelligence Quotient\<70);
* Prior tDCS or TMS treatment within the past 3 months;
* Contraindications for TMS therapy (e.g., intracranial metal implants, history of traumatic brain injury, skull defects, cardiac pacemakers, cardiovascular diseases, or epilepsy);
* Severe somatic diseases or major organ dysfunction;
* Psychiatric disorders per DSM-5 criteria (e.g., schizophrenia, schizoaffective disorder, intellectual disability, autism spectrum disorder, dementia, memory impairment, or other cognitive disorders);

Primary outcomes:
measure: The change of alcohol craving
timeFrame: 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
measure: The change of relapse behaviors with alcohol
timeFrame: 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
measure: The change of drinking symptom
timeFrame: 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
Secondary outcomes:
measure: The change of sleep
timeFrame: 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
measure: The change of depression
timeFrame: 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
measure: The change of anxiety
timeFrame: 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
measure: The change of self-control
timeFrame: baseline, immediately after the intervention.
Other outcomes:
measure: The Change of Heart Rate Variability
timeFrame: baseline, immediately after the intervention
measure: The Change of Functional Connectivity
timeFrame: baseline, immediately after the intervention
measure: The change of EEG
timeFrame: baseline, immediately after the intervention
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Jiang Du, M.D, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: