Ignite Creation Date:
2024-05-06 @ 7:15 PM
Last Modification Date:
2024-10-26 @ 3:03 PM
Study NCT ID:
NCT05947656
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2023-06-20
Brief Title:
Evaluation of the NaviFUS System in Drug Resistant Epilepsy
Sponsor:
Genovate-NaviFUS Australia Pty Ltd
Organization:
Genovate Biotechnology Co Ltd
Study Overview
Official Title:
An Open-label Non-randomized Single-arm Pilot Study to Evaluate the Safety and Efficacy of Multiple Pulsed Focused Ultrasound Treatment in Patients With Drug Resistant Temporal Lobe Epilepsy
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Participants with drug-resistant epilepsy DRE enrolled in this study will receive focused ultrasound FUS treatment with the NaviFUS System guided by the neuronavigation system to evaluate the safety and efficacy of using NaviFUS System During the treatment the FUS will electronically scan and target to the assigned zones on one or both of the hippocampi
The study consists of a 60-day screening period for baseline observation prior to treatment a FUS treatment period of 2 weeks for Cohort 1 or 3 weeks for Cohort 2 with 2 FUS treatments per week using the NaviFUS System and a safety follow-up period of 81 days
The study consists of a 60-day screening period for baseline observation prior to treatment a FUS treatment period of 2 weeks for Cohort 1 or 3 weeks for Cohort 2 with 2 FUS treatments per week using the NaviFUS System and a safety follow-up period of 81 days
Detailed Description:
Up to 30 of patients with epilepsy are resistant to current anti-seizure medications ie drug-resistant epilepsy DRE Resective surgery of the epileptogenic regions is the most effective option to treat patients with DRE Unfortunately up to 60 of DRE patients are not suitable for resective surgery
Neuromodulation approaches are increasingly being utilized in patients with DRE The current approved techniques use invasive neuromodulation which require complex neurosurgery and could cause side effects such as infection bleeding and non-target brain tissue damage
Focused ultrasound is a novel noninvasive therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with epilepsy NaviFUS System a neuro-navigation guided focused ultrasound system is one of the FUS technologies that uses low-intensity focused ultrasound LIFU phased array system to deliver transcranial burst-mode ultrasound energy to induce neuromodulation effect and block signals in a specific area of the brain that cause symptoms of epilepsy such as seizures The pilot clinical study has demonstrated that NaviFUS System safely delivered LIFU to the seizure onset zone and modulated the neuronal activity
Neuromodulation approaches are increasingly being utilized in patients with DRE The current approved techniques use invasive neuromodulation which require complex neurosurgery and could cause side effects such as infection bleeding and non-target brain tissue damage
Focused ultrasound is a novel noninvasive therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with epilepsy NaviFUS System a neuro-navigation guided focused ultrasound system is one of the FUS technologies that uses low-intensity focused ultrasound LIFU phased array system to deliver transcranial burst-mode ultrasound energy to induce neuromodulation effect and block signals in a specific area of the brain that cause symptoms of epilepsy such as seizures The pilot clinical study has demonstrated that NaviFUS System safely delivered LIFU to the seizure onset zone and modulated the neuronal activity
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