Psychostimulant Use Disorder(PUD)NCT06474026
Bilateral Nucleus Accumbens Focused Ultrasound Neuromodulation for Stimulant Use Disorder
A study testing ExAblate 4000 Type 2.1 in people with Psychostimulant Use Disorder(PUD), run by Korea University Anam Hospital at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Psychostimulant Use Disorder(PUD)
- What is being tested?
- ExAblate 4000 Type 2.1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 36Show fewer
- 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
- Unstable or worsening congestive heart failure
- Left ventricular ejection fraction (LVEF) below the lower limit of normal
- History of hemodynamically unstable cardiac arrhythmias
- Cardiac pacemaker
- Severe hypertension (diastolic blood pressure over 100 on medication)
- Subject has a history of abnormal bleeding or coagulopathy
- Subject is receiving anticoagulant (e.g., warfarin) or antiplatelet (e.g., aspirin) therapy within one week of focused ultrasound procedure or drugs known to increase risk of hemorrhage (e.g., Avastin) within one month of focused ultrasound procedure
- Subject has blood coagulation test results outside the normal range
- PLT<100,000/μL
- PT>13.9 seconds or PTT>37.5 seconds
- INR>1.2
- Subject with cerebrovascular disease as determined by MRI according to Fazekas score
- Subject with a past or current diagnosis of schizophrenia, psychotic disorder, bipolar disorder, or untreated depression other than one determined to be substance induced
- Score of greater than 17 on the Hamilton Depression Rating Scale (HAM-D) or increased risk of suicide based on any positive response regarding passive or active suicidal ideation with or without intent over the past 3 months or lifetime history of active suicidal ideation with intent on the Columbia-Suicide Severity Rating Scale (C-SSRS) at baseline
- Diagnosis of dementia or any other disorder which has led to a clinically significant cognitive impairment (assessed via NIHTB-CB)
- Subject with brain tumors
- Subject with chronic pulmonary disorders e.g. severe emphysema, pulmonary vasculitis, or other casues of reduced pulmonary vascular cross-sectional area.
- Any known CNS infection or infection with the human immunodeficiency virus (HIV)
- Subject who has had deep brain stimulation or a prior stereostatic ablation of the NAc, basal ganglia, or thalamus
- Subject who has been administered botulinum toxins into to the arm, neck, or face for 5 months prior to baseline
- Subject unwilling to refrain from using illicit drugs while participating in this clinical trial
- Subject is pregnant or nursing women
- For women of childbearing potential*, who do not agree to use clinically appropriate contraception** for the duration of the clinical trial
- Definition of women of childbearing age: means women who have experienced menarche, have not been surgically sterilized (hysterectomy or bilateral oophorectomy), or are not post-menopausal, defined as amenorrhea for 12 months or more for no other reason.
- Clinically appropriate contraception: defined as "[intrauterine device (e.g., Loop, Mirena), chemical barrier method (spermicide), or subdermal implantable contraceptive device (e.g., Implanon)] + physical barrier method (male or female)" for women, tubal surgery, or laparoscopic contraception (a type of tubal ligation).
- Other, if the investigator determines that participation in the clinical trial is inappropriate ethically or because it may affect the outcome of the clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, Seoul, 02841
Kweon, eun jung, 82+02-920-5696, kweonej@kumc.or.kr
About this study
Official title: Safety and Preliminary Efficacy of Bilateral Nucleus Accumbens-Targeted Low-Intensity Focused Ultrasound Neuromodulation Using ExAblate 4000 Type 2.1 in Patients With Stimulant Use Disorder: A Single-Center, Prospective, Single-Arm, Open-Label, Investigator-Initiated Feasibility 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).
Read the detailed description
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.
- Conditions
- Psychostimulant Use Disorder(PUD)
- Being tested
- ExAblate 4000 Type 2.1
- Keywords
- ExAblate 4000 Type 2.1, Psychostimulant use disorder, neuromodulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExAblate 4000 Type 2.1Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm: | Experimental | Visit 2(Procedure) Receives: Device: ExAblate 4000 Type 2.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of psychostimulant abstinence (%)
Percentage of subjects with no detectable psychostimulants and other illicit drugs by urine toxicology screening after application
Measured: 7, 30, 90, and 180 days after device application
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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
Measured: Baseline to 7, 30, 90, and 180 days after device application
Assessment of cognitive function
Change in Cognitive Function Assessment (points) Post-device application
Measured: 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.
Measured: Baseline to 7 days and 90 days after device application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Jul 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychostimulant Use Disorder(PUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chang, Jin Woo, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474026
- Sponsor's protocol ID
- KUAHPD-01
- Status last verified
- Aug 2026
- First submitted
- 19 Jun 2024
- Last updated
- 24 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Preliminary Efficacy of Bilateral Nucleus Accumbens-Targeted Low-Intensity Focused Ultrasound Neuromodulation Using ExAblate 4000 Type 2.1 in Patients With Stimulant Use Disorder: A Single-Center, Prospective, Single-Arm, Open-Label, Investigator-Initiated Feasibility Trial
- ClinicalTrials.gov ID
- NCT06474026
- Acronym / sponsor ID
- KUAHPD-01
- Conditions
- Psychostimulant Use Disorder(PUD)
- Keywords
- ExAblate 4000 Type 2.1, Psychostimulant use disorder, neuromodulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 25 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm: | Experimental | Device: ExAblate 4000 Type 2.1Visit 2(Procedure) |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (36 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExAblate 4000 Type 2.1In 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. | Device | Treatment arm: |
Primary outcome
Success rate of psychostimulant abstinence (%)
Time frame: 7, 30, 90, and 180 days after device application
Percentage of subjects with no detectable psychostimulants and other illicit drugs by urine toxicology screening after application
5 secondary outcomes
Time to relapse (in days)
Time frame: 6 months
Visual Analog Scale rating of craving severity
Time frame: Baseline to 7, 30, 90, and 180 days after device application
Assessments related to mood/anxiety/attention/impulsivity
Time frame: Baseline to 7, 30, 90, and 180 days after device application
Assessment of cognitive function
Time frame: Baseline to 180 days after device application
Evaluation of resting-state functional connectivity (RSFC) and fMRI drug cue reactivity (FDCR)
Time frame: Baseline to 7 days and 90 days after device application
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExAblate 4000 Type 2.1 in people with Psychostimulant Use Disorder(PUD), run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of psychostimulant abstinence (%) (time frame: 7, 30, 90, and 180 days after device application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.