Safety and Efficacy of Neuromodulation Using 'ExAblate 4000 Type 2.1' in Patients With Psychostimulant Use Disorder(PUD): a Single-center, Evaluators-blind, Prospective, Randomized, Feasibility, Investigator-initiated Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Psychostimulant Use Disorder(PUD)
- Sponsor
- Korea University Anam Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Success rate of psychostimulant abstinence (%)
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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).
Detailed Description
This clinical trial aims to evaluate the safety and efficacy of neuromodulation using 'ExAblate 4000 Type 2.1' in patients with psychostimulant use disorder (PUD). It is designed as a single-center, open, prospective, randomized, feasibility, investigator-initiated trial. Patients with psychostimulant use disorder (PUD) will be referred to this clinical trial. Those who have been fully informed about the clinical trial and voluntarily sign an informed consent form will undergo screening tests. After checking all inclusion/exclusion eligibility, the Investigator will assign randomization numbers and randomize subjects to SHAM+ACTIVE or ACTIVE arm in a 1:1 ratio, and finally enroll subjects in this clinical trial. Subjects will receive an investigational medical device as described below based on their arm assignment at Visit 2. The investigator will perform neuromodulation of the bilateral nucleus accumbens using the investigational medical device "ExAblate 4000 Type 2.1". At the end of the procedure, the subject will be observed for at least 2 hours after application of the investigational medical device. At this point, the investigator will confirm the occurrence of the adverse event that may cause the dropout as below. If the subject is dropped out, follow-up observation of the adverse event continues. 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. All subjects will complete a follow-up evaluation at Visit 6 (Day 180±7) after the ACTIVE device procedure and will exit the clinical trial if no adverse events have occurred or if the investigator determines that no further follow-up for adverse events is necessary. The primary endpoint includes the success rate of psychostimulant abstinence (%). The secondary endpoint includes time to recurrence (in days), VAS rating of craving severity (mm), assessments related to mood/anxiety/attention/impulsivity, assessment of cognitive function, evaluation of fMRI drug cue reactivity (FDCR) in neural signaling of drug craving (including striatum, orbitofrontal cortex, amygdala, and synapses).
Investigators
Chang, Jin Woo
Professor
Korea University Anam Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Success rate of psychostimulant abstinence (%)
Time Frame: 7, 30, 90, and 180 days after ACTIVE device application
Percentage of subjects with no detectable psychostimulants and other illicit drugs by urine toxicology screening after application
Secondary Outcomes
- 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)
- Time to recurrence (in days)(6 months)
- 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)