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RECRUITING
NCT06474026
NA

Bilateral Nucleus Accumbens Focused Ultrasound Neuromodulation for Stimulant Use Disorder

Sponsor: Korea University Anam Hospital

View on ClinicalTrials.gov

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).

Official title: Safety and Preliminary Efficacy of Bilateral Nucleus Accumbens-Targeted Low-Intensity Focused Ultrasound Neuromodulation Using ExAblate 4000 Type 2.1 in Patients With Stimulant Use Disorder: A Single-Center, Prospective, Single-Arm, Open-Label, Investigator-Initiated Feasibility Trial

Key Details

Gender

All

Age Range

19 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2024-07-01

Completion Date

2027-07-31

Last Updated

2026-08-24

Healthy Volunteers

No

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.

Locations (1)

Korea University Anam Hospital

Seoul, Seoul, South Korea