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).
Adults between the ages of 19 and 60
Subject is diagnosed with a DSM-5 psychostimulant* use disorder (PUD) by a board certified psychiatrist.
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 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.
Parallel
ExAblate 4000 Type 2.1
DeviceIn 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.
Success rate of psychostimulant abstinence (%)
Percentage of subjects with no detectable psychostimulants and other illicit drugs by urine toxicology screening after application
Time to recurrence (in days)
Mean time to relapse for subjects with psychostimulants and other illicit drugs detected by urine toxicology screening after application of the ACTIVE device
Visual Analog Scale rating of craving severity (mm)
Change in substance craving visual analog scale (VAS, 0\~100mm) score after sham or active device application. 0 indicates no craving at all, while 100 indicates the maximum craving.
Assessments related to mood/anxiety/attention/impulsivity
Change (in points) in assessments of mood/anxiety/attention/impulsivity
Assessment of cognitive function
Change in Cognitive Function Assessment (points) Post-ACTIVE Device application
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