Actively Recruiting
Evaluation of the NaviFUS System in Drug Resistant Epilepsy
Led by Genovate-NaviFUS (Australia) Pty Ltd. · Updated on 2025-07-03
18
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
G
Genovate-NaviFUS (Australia) Pty Ltd.
Lead Sponsor
G
Genovate Biotechnology Co., Ltd.,
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of the NaviFUS System in Drug Resistant Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of drug resistant temporal lobe epilepsy (TLE)
- At least four observable seizures on separate days during the 60-day baseline period
- Focal-onset seizures with or without secondary generalization
- Completed at least 24 hours of video-electroencephalography (EEG) monitoring confirming TLE
- Stable seizure medication treatment expected during the trial, except for rescue or occasional extra doses
- Ability and willingness to complete assessments and neuropsychological testing in English, alone or with a study partner
- Reliable patient and study partner able to use seizure diary and comply with study procedures and visits
You will not qualify if you...
- Primary generalized epilepsy or non-epileptic seizures in the last 2 years
- More than two seizure onset zones (except bitemporal) or unknown seizure onset location
- Tonic-clonic status epilepticus within 3 months before enrollment
- Presence of implanted devices like pacemaker, defibrillator, permanent medication pumps, cochlear implants, responsive neurostimulator, or deep brain stimulation
- Clips or metallic implants in the ultrasound exposure path, except shunts
- More than 30% of skull area with scars, scalp disorders, or atrophy at screening
- Severe systemic diseases such as heart disease, uncontrolled hypertension, severe pulmonary hypertension, COPD, liver or kidney insufficiency, or poorly controlled diabetes
- History of intracranial hemorrhage or multiple strokes, or stroke within 6 months before screening
- Intracranial aneurysms or arteriovenous malformations requiring treatment
- Central nervous system diseases other than epilepsy, including infections and brain injury within 3 years
- Major psychiatric disorders or psychiatric hospitalization within 1 year before screening
- Cancer diagnosis or ongoing malignancy within past 2 years (except certain treated skin or in situ cancers)
- Unable or unwilling to tolerate prolonged semi-supine position during treatment
- Contraindications to MRI or inability to tolerate MRI procedures
- Major surgery within 6 weeks before enrollment, not fully recovered, or planned surgery during study or within 14 days after
- Received radiofrequency thermocoagulation within 2 months of screening
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The Alfred
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
C
Caitlin Roberts, Ms.
CONTACT
J
Jack Germaine, Mr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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