NCT06474026

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Korea University Anam Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This clinical trial aims to evaluate the safety and efficacy of neuromodulation using 'ExAblate 4000 Type 2.1' in patients with psychostimulant use disorder (PUD). It is designed as a single-center, open, prospective, randomized, feasibility, investigator-initiated trial. Patients with psychostimulant use disorder (PUD) will be referred to this clinical trial. Those who have been fully informed about the clinical trial and voluntarily sign an informed consent form will undergo screening tests. After checking all inclusion/exclusion eligibility, the Investigator will assign randomization numbers and randomize subjects to SHAM+ACTIVE or ACTIVE arm in a 1:1 ratio, and finally enroll subjects in this clinical trial. Subjects will receive an investigational medical device as described below based on their arm assignment at Visit 2. The investigator will perform neuromodulation of the bilateral nucleus accumbens using the investigational medical device "ExAblate 4000 Type 2.1". At the end of the procedure, the subject will be observed for at least 2 hours after application of the investigational medical device. At this point, the investigator will confirm the occurrence of the adverse event that may cause the dropout as below. If the subject is dropped out, follow-up observation of the adverse event continues. 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. All subjects will complete a follow-up evaluation at Visit 6 (Day 180±7) after the ACTIVE device procedure and will exit the clinical trial if no adverse events have occurred or if the investigator determines that no further follow-up for adverse events is necessary. The primary endpoint includes the success rate of psychostimulant abstinence (%). The secondary endpoint includes time to recurrence (in days), VAS rating of craving severity (mm), assessments related to mood/anxiety/attention/impulsivity, assessment of cognitive function, evaluation of fMRI drug cue reactivity (FDCR) in neural signaling of drug craving (including striatum, orbitofrontal cortex, amygdala, and synapses).

Conditions

• Psychostimulant Use Disorder(PUD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2024-06-25
• Last updated: 2025-09-05

Locations

1 site across 1 country: South Korea