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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-60
SponsorKorea University Anam Hospital

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

Treatment groups

10 Participants
are divided into 2 treatment groups

Sponsors and collaborators