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

NCT06474026 | Recruiting

• 1 other identifier: KUAHPD-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

ExAblate 4000 Type 2.1; Psychostimulant use disorder; neuromodulation

Outcome Measures

Primary Outcomes (1)

• Success rate of psychostimulant abstinence (%)

  Percentage of subjects with no detectable psychostimulants and other illicit drugs by urine toxicology screening after application

  7, 30, 90, and 180 days after ACTIVE device application

Secondary Outcomes (5)

• Time to recurrence (in days)

  6 months

• Visual Analog Scale rating of craving severity (mm)

  Baseline to 7 days after SHAM device application, baseline to 7, 30, 90, and 180 days post ACTIVE device

• Assessments related to mood/anxiety/attention/impulsivity

  Baseline to 7 days after SHAM device application, baseline to 7, 30, 90, and 180 days post ACTIVE device

• Assessment of cognitive function

  Baseline to 180 days post-ACTIVE Device application

• Evaluation of fMRI drug cue reactivity (FDCR) in neural signaling of drug craving (including striatum, orbitofrontal cortex, amygdala, and synapses)

  Baseline to 7 days after SHAM device application, Baseline to 7 days and 180 days after active device application

Study Arms (2)

Active arm:

EXPERIMENTAL

Visit 2(Active procedure)

Device: ExAblate 4000 Type 2.1

Sham+Active arm

SHAM COMPARATOR

Visit 2-1(Sham procedure), Visit 2-2(7±2 days after applying sham device): evaluate safety and effectiveness for SHAM devices, Active procedure

Device: ExAblate 4000 Type 2.1

Interventions

ExAblate 4000 Type 2.1 DEVICE

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.

Active arm:; Sham+Active arm

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults between the ages of 19 and 60
• Subject is diagnosed with a DSM-5 psychostimulant\* use disorder (PUD) by a board certified psychiatrist.
• \*Psychostimulants: Methamphetamine, cocaine, and other stimulants
• Subject is currently receiving standard substance use disorder inpatient treatment or an intensive outpatient program
• Subject has been off psychostimulants and other illicit drugs, confirmed via urine toxicology screen
• Subject has not regularly used illegal drugs other than psychostimulants more than once a month in the past six months
• The NAc is apparent on MRI such that treatment targeting can be performed directly (visible on MRI) and indirectly (using other anatomical structures for measurements)
• Subject is able to communicate sensations during the investigational procedure
• Subject has made a voluntary decision to participate in this clinical trial and has given written consent.
• Subject is willing to comply to the protocol

You may not qualify if:

• Subject with standard contraindication for MR imaging, such as non-MRI compatible implanted metallic devices.
• Subject with known allergies to the MRI contrast agent gadolinium (Gadovist®) or contraindication (such as untreated hypokalemia).
• Subject who are unable or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours)
• More than 30% of the skull area traversed by the sonication pathyway is covered by scars, scalp disorder (e.g., eczema), or atrophy of the scalp.
• Subject with implanted objects in the skull or brain
• Subject diagnosed with advanced kidney disease or on dialysis
• Subjet with impaired renal function with estimated glomerular filtration rate less than 30 mL/min/1.73 m 2
• Subject with known unstable cardiac status or severe hypertension including:
• Documented myocardial infarction within six months of enrollment
• Unstable angina on medication
• Unstable or worsening congestive heart failure
• Left ventricular ejection fraction (LVEF) below the lower limit of normal
• History of hemodynamically unstable cardiac arrhythmias
• Cardiac pacemaker
• Severe hypertension (diastolic blood pressure over 100 on medication)

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, Seoul, 02841, South Korea

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-06

Locations

KR (1)