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

NCT ID: NCT06867224

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2027-01-01

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.

Conditions

Alcohol Use Disorder (AUD); Transcranial Ultrasound Stimulation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Intervention group

The active group will receive active transcranial ultrasound stimulation.

Group Type: EXPERIMENTAL

Active TUS-vmPFC

Intervention Type: DEVICE

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.

Control group

The sham group will receive shame transcranial ultrasound stimulation.

Group Type: SHAM_COMPARATOR

Shame TUS-vmPFC

Intervention Type: DEVICE

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.

Interventions

Shame TUS-vmPFC

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.

Intervention Type: DEVICE

Active TUS-vmPFC

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.

Intervention Type: DEVICE

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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Mental Health Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiang Du, M.D, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Shanghai Mental Health Center

Locations

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

JDu-014

Identifier Type: -

Identifier Source: org_study_id