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RECRUITING
NCT06474026
NA

A Clinical Trial to Evaluate the Safety and Efficacy of Neuromodulation Using 'ExAblate 4000 Type 2.1' in Patients With Psychostimulant Use Disorder(PUD)

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 Efficacy of Neuromodulation Using 'ExAblate 4000 Type 2.1' in Patients With Psychostimulant Use Disorder(PUD): a Single-center, Evaluators-blind, Prospective, Randomized, Feasibility, Investigator-initiated Trial

Key Details

Gender

All

Age Range

19 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-07-01

Completion Date

2026-07-31

Last Updated

2025-09-05

Healthy Volunteers

No

Interventions

DEVICE

ExAblate 4000 Type 2.1

In Sham+Active arm, the subject will receive sham device application(Visit 2-1) and then active device application(Visit 2-2) after 7±2 days. In Active arm, the subject will receive active device application(Visit 2) Subjects will return to the site at Visit 3 (7±2 days post-active device application), Visit 4 (30±7 days post-active device application), Visit 5 (90±7 days post-active device application), and Visit 6 (180±7 days post-active device application) for safety and efficacy assessments.

Locations (1)

Korea University Anam Hospital

Seoul, Seoul, South Korea