Transcranial Ultrasound Stimulation as a Neuromodulation Therapy for Craving and Relapse Behaviors in Alcohol Use Disorder.

Shanghai Mental Health Center

Status: Active, not recruiting

Conditions: Alcohol Use Disorder (AUD); Transcranial Ultrasound Stimulation

Treatments: Device: Shame TUS-vmPFC; Device: Active TUS-vmPFC

Study type: Interventional

Funder types: Other

Identifiers

NCT06867224

JDu-014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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);

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Intervention group

Experimental group

Description:

The active group will receive active transcranial ultrasound stimulation.

Treatment:

Device: Active TUS-vmPFC

Control group

Sham Comparator group

Description:

The sham group will receive shame transcranial ultrasound stimulation.

Treatment:

Device: Shame TUS-vmPFC