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Bilateral Nucleus Accumbens Focused Ultrasound Neuromodulation for Stimulant Use Disorder

NCT06474026 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-08-24

No results posted yet for this study

Summary

The purpose of this clinical trial is to evaluate the initial safety and efficacy of the ExAblate Model 4000 Type 2.1 surgical device for nucleus accumbens (NAc) neuromodulation in patients with psychostimulant use disorder (PUD).

Conditions

  • Psychostimulant Use Disorder(PUD)

Interventions

DEVICE

ExAblate 4000 Type 2.1

In treatment arm, the subject will receive device application(bilateral NAc FUS; Visit 2) Subjects will return to the site at Visit 3 (7±2 days post device application), Visit 4 (30±7 days post device application), Visit 5 (90±7 days post device application), and Visit 6 (180±7 days post device application) for safety and efficacy assessments.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2027-07-31
Completion
2027-07-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06474026 on ClinicalTrials.gov