Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06474026
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2024-06-19
Brief Title:
A Clinical Trial to Evaluate the Safety and Efficacy of Neuromodulation Using High Intensity Focused Ultrasound ExAblate 4000 Type 21 in Patients With Psychostimulant Use DisorderPUD
Sponsor:
Korea University Anam Hospital
Organization:
Korea University Anam Hospital
Study Overview
Official Title:
Safety and Efficacy of Neuromodulation Using High Intensity Focused Ultrasound ExAblate 4000 Type 21 in Patients With Psychostimulant Use DisorderPUD a Single-center Open Prospective Randomized Feasibility Investigator-initiated Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to evaluate the initial safety and efficacy of the ExAblate Model 4000 Type 21 high-intensity focused ultrasound 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 high intensity focused ultrasound ExAblate 4000 Type 21 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 inclusionexclusion eligibility the Investigator will assign randomization numbers and randomize subjects to SHAMACTIVE or ACTIVE arm in a 11 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 21 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 72 days post-active device application Visit 4 307 days post-active device application Visit 5 907 days post-active device application and Visit 6 1807 days post-active device application for safety and efficacy assessments All subjects will complete a follow-up evaluation at Visit 6 Day 1807 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 moodanxietyattentionimpulsivity assessment of cognitive function evaluation of fMRI drug cue reactivity FDCR in neural signaling of drug craving including striatum orbitofrontal cortex amygdala and synapses
The investigator will perform neuromodulation of the bilateral nucleus accumbens using the investigational medical device ExAblate 4000 Type 21 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 72 days post-active device application Visit 4 307 days post-active device application Visit 5 907 days post-active device application and Visit 6 1807 days post-active device application for safety and efficacy assessments All subjects will complete a follow-up evaluation at Visit 6 Day 1807 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 moodanxietyattentionimpulsivity assessment of cognitive function evaluation of fMRI drug cue reactivity FDCR in neural signaling of drug craving including striatum orbitofrontal cortex amygdala and synapses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None