Ignite Creation Date:
2024-07-17 @ 11:12 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492720
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-01
Brief Title:
A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
Sponsor:
NaviFUS Corporation
Organization:
NaviFUS Corporation
Study Overview
Official Title:
A Pilot Open-label Two-arm Parallel-group Randomized Trial Study to Evaluate the Efficacy and Safety of NaviFUS System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
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:
This will be a prospective pilot open-label two-arm parallel-group randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound LIFU neuromodulation using NaviFUS System in patients with drug-resistant epilepsy DRE
Detailed Description:
The study aims to demonstrate the efficacy and safety of LIFU neuromodulation in DRE patients showing its ability to decrease targeted neuronal activity and alleviate epileptic seizures
Drug-resistant epilepsy at least 3 anti-seizure medication failed patients whose epileptogenic foci have been determined by comprehensive presurgical evaluation and meet all eligibility criteria may participate in this study by providing informed consent Eligible patients will undergo a 8-week baseline observation screening period and will be asked to keep a 8-week seizure diary This diary will serve as a baseline prior to treatment and will continue to be recorded throughout the treatment and follow-up period
This study will enroll a maximum of 16 eligible patients Eligible patients will be randomized into two groups to receive three-consecutive 5-minute twice low dose group or three-consecutive 10-minute FUS treatment twice high dose group in a week using assigned ultrasound exposure doses generated by the NaviFUS System Following treatment there will be a 24-week follow-up period Patients will be allowed concomitant use of anti-seizure medications ASMs throughout the whole study period
Drug-resistant epilepsy at least 3 anti-seizure medication failed patients whose epileptogenic foci have been determined by comprehensive presurgical evaluation and meet all eligibility criteria may participate in this study by providing informed consent Eligible patients will undergo a 8-week baseline observation screening period and will be asked to keep a 8-week seizure diary This diary will serve as a baseline prior to treatment and will continue to be recorded throughout the treatment and follow-up period
This study will enroll a maximum of 16 eligible patients Eligible patients will be randomized into two groups to receive three-consecutive 5-minute twice low dose group or three-consecutive 10-minute FUS treatment twice high dose group in a week using assigned ultrasound exposure doses generated by the NaviFUS System Following treatment there will be a 24-week follow-up period Patients will be allowed concomitant use of anti-seizure medications ASMs throughout the whole study period
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