About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- ExAblate 4000 Type 2.1