Actively Recruiting
A Clinical Trial to Evaluate the Safety and Efficacy of Neuromodulation Using 'ExAblate 4000 Type 2.1' in Patients With Psychostimulant Use Disorder(PUD)
Led by Korea University Anam Hospital · Updated on 2025-09-05
10
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Clinical Trial to Evaluate the Safety and Efficacy of Neuromodulation Using 'ExAblate 4000 Type 2.1' in Patients With Psychostimulant Use Disorder(PUD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults between the ages of 19 and 60
- Diagnosed with DSM-5 psychostimulant use disorder by a board certified psychiatrist
- Currently receiving standard inpatient or intensive outpatient substance use disorder treatment
- Off psychostimulants and other illicit drugs confirmed by urine toxicology screen
- No regular use of illegal drugs other than psychostimulants more than once a month in the past six months
- Nucleus accumbens visible on MRI for treatment targeting
- Able to communicate sensations during the procedure
- Voluntarily agreed to participate and signed informed consent
- Willing to follow the study protocol
You will not qualify if you...
- Standard contraindications for MRI such as non-MRI compatible implanted metal devices
- Known allergies to MRI contrast agent gadolinium or contraindications like untreated low potassium
- Unable or unwilling to tolerate staying still for 2-3 hours during treatment
- More than 30% of skull area in treatment path covered by scars, scalp disorders, or atrophy
- Implanted objects in the skull or brain
- Advanced kidney disease or dialysis
- Impaired kidney function with low filtration rate
- Unstable heart conditions or severe hypertension including recent heart attack or heart failure
- History of abnormal bleeding or blood clotting disorders
- Taking anticoagulant or antiplatelet therapy close to treatment time
- Blood coagulation test results outside normal range
- Cerebrovascular disease shown by MRI
- Past or current schizophrenia, psychotic disorder, bipolar disorder, or untreated depression not substance-induced
- High depression score or increased suicide risk
- Dementia or significant cognitive impairment
- Brain tumors
- Chronic severe lung diseases
- Known CNS infection or HIV infection
- Previous deep brain stimulation or brain ablation in target areas
- Botulinum toxin injections in arm, neck, or face within 5 months
- Unwilling to avoid illicit drug use during study
- Pregnant or nursing women
- Women of childbearing potential not agreeing to use appropriate contraception during study
- Any other condition the investigator deems unsuitable for participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Korea University Anam Hospital
Seoul, Seoul, South Korea, 02841
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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