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).
This prospective, single-center, single-arm, open-label feasibility trial is designed to evaluate the safety and preliminary efficacy of nucleus accumbens (NAc)-targeted neuromodulation using the ExAblate 4000 Type 2.1 system in patients with psychostimulant use disorder (PUD). Potential participants with PUD who are receiving standard treatment for substance use disorder will be informed about the study and invited to participate. Individuals who voluntarily provide written informed consent will undergo screening assessments to determine eligibility according to the predefined inclusion and exclusion criteria. Eligible participants will then be enrolled in the study. At Visit 2, participants will undergo focused ultrasound neuromodulation targeting the bilateral NAc using the ExAblate 4000 Type 2.1 system. The procedure will be performed under magnetic resonance imaging guidance. Following completion of the procedure, participants will be clinically observed for at least 2 hours and assessed for any procedure- or device-related adverse events. Participants who discontinue the study because of an adverse event will continue to be followed as clinically appropriate until the event has resolved or stabilized, or until the investigator determines that further follow-up is no longer necessary. Participants will return for follow-up assessments at Visit 3 (Day 7 ± 2), Visit 4 (Day 30 ± 7), Visit 5 (Day 90 ± 7), and Visit 6 (Day 180 ± 7) after the focused ultrasound procedure. Safety assessments will include monitoring for adverse events and clinically relevant neurological or medical changes. Efficacy assessments will include urine toxicology testing for psychostimulant and illicit drug use, assessment of time to relapse, evaluation of substance craving, psychiatric and behavioral assessments related to mood, anxiety, attention, and impulsivity, and assessment of cognitive function. Functional magnetic resonance imaging, including a drug-cue reactivity paradigm, will also be performed at predefined study time points to evaluate longitudinal changes in neural responses associated with drug craving. All participants will complete the final study evaluation at Visit 6 (Day 180 ± 7). Participants with unresolved adverse events may continue to be followed beyond the final scheduled visit when considered clinically necessary by the investigator.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
In treatment arm, the subject will receive device application(bilateral NAc FUS; Visit 2) Subjects will return to the site at Visit 3 (7±2 days post device application), Visit 4 (30±7 days post device application), Visit 5 (90±7 days post device application), and Visit 6 (180±7 days post device application) for safety and efficacy assessments.
Korea University Anam Hospital
Seoul, Seoul, South Korea
RECRUITINGSuccess rate of psychostimulant abstinence (%)
Percentage of subjects with no detectable psychostimulants and other illicit drugs by urine toxicology screening after application
Time frame: 7, 30, 90, and 180 days after device application
Time to relapse (in days)
Time in days from active sonication to the first positive urine toxicology result indicating psychostimulant relapse. Participants without a positive urine toxicology result are followed through Day 180.
Time frame: 6 months
Visual Analog Scale rating of craving severity
Change in substance craving visual analog scale (VAS, 0-10) score after device application. Craving is rated on a 0-10 visual analog scale, where 0 indicates no craving and 10 indicates the strongest craving ever.
Time frame: Baseline to 7, 30, 90, and 180 days after device application
Assessments related to mood/anxiety/attention/impulsivity
Change (in points) in assessments of mood/anxiety/attention/impulsivity
Time frame: Baseline to 7, 30, 90, and 180 days after device application
Assessment of cognitive function
Change in Cognitive Function Assessment (points) Post-device application
Time frame: Baseline to 180 days after device application
Evaluation of resting-state functional connectivity (RSFC) and fMRI drug cue reactivity (FDCR)
Change in resting-state functional connectivity (RSFC) and fMRI drug cue reactivity (FDCR) after device application. RSFC assesses longitudinal changes in functional connectivity across brain networks at rest, while FDCR assesses longitudinal changes in BOLD responses to drug-related versus neutral cues.
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Time frame: Baseline to 7 days and 90 days after device application