Actively Recruiting
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
Led by Genovate-NaviFUS (Australia) Pty Ltd. · Updated on 2025-07-03
18
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating the safety and effectiveness of the NaviFUS System, a non-invasive focused ultrasound device, in treating patients with drug-resistant temporal lobe epilepsy (DRE). This condition affects up to 30% of epilepsy patients who do not respond to medications, and many are not suitable for surgery. The NaviFUS System aims to deliver low-intensity focused ultrasound to targeted areas of the brain to reduce seizure activity, offering a potential alternative to invasive neuromodulation therapies. Participants will undergo a 60-day baseline screening period, followed by treatment with the NaviFUS System. Eligible patients are assigned to one of two groups: Cohort 1 receives two treatments per week for two weeks (four treatments total), and Cohort 2 receives two treatments per week for three weeks (six treatments total). The treatment targets one or both hippocampi using neuronavigation guidance. After treatment, participants complete a safety follow-up period lasting approximately 81 days. Throughout the study, participants will have multiple assessments including physical, neurological, and cognitive tests to monitor safety and effects. These include detailed cognitive tests like the Boston Naming Test and Wechsler Memory Scale, MRI scans, electrocardiograms, and seizure diary tracking. Safety is closely monitored up to three months after the last treatment session. The total study duration involves screening, treatment, and follow-up visits spanning several months.
CONDITIONS
Brief 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)
- Experience at least four (4) observable seizures over the 60-day baseline, each on a separate day
- Have focal-onset seizures with or without secondary generalization
- Completed at least 24 hours of video-electroencephalography (EEG) monitoring and comprehensive epilepsy evaluation confirming TLE
- Seizure medication treatment expected to remain stable during the trial, except for rescue or occasional extra doses
- Capable and willing to complete assessments and neuropsychological testing in English alone or with study partner help
- Reliable and able to use a seizure diary to record seizures and comply with study procedures and visits
You will not qualify if you...
- Primary generalized epilepsy or non-epileptic seizures in the last two (2) years
- More than two (2) seizure onset zones (except bitemporal foci) or unknown seizure origin
- Experienced tonic-clonic status epilepticus in the three (3) months before enrollment
- Presence of devices like pacemakers, implantable cardioverter-defibrillator, medication pumps, cochlear implants, responsive neurostimulator or deep brain stimulation; vagus nerve stimulators allowed if stable
- Clips or metallic implants in the focused ultrasound exposure path, except shunts
- More than 30% of skull area in the sonication pathway covered by scars, scalp disorders, or atrophy at screening
- Severe systemic diseases such as heart disease, uncontrolled hypertension, severe pulmonary hypertension, COPD, hepatic or renal insufficiency, or poorly controlled diabetes
- History of intracranial hemorrhage, multiple strokes, or recent stroke within six (6) months
- Intracranial aneurysms or arteriovenous malformations requiring treatment
- Central nervous system diseases other than epilepsy including infections, cerebral vascular disease, Parkinson's disease, traumatic brain injury, or alcoholic encephalopathy
- Major psychiatric disorders including schizophrenia, bipolar disorder, severe depression, active suicidal ideation, active psychosis, or recent psychiatric hospitalization
- Prior cancer diagnosis within two (2) years with ongoing malignancy 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 six (6) weeks before enrollment or planned surgery during study or shortly after
- Received radiofrequency thermocoagulation (RFTC) within two (2) months of screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks for Cohort 1; 3 weeks for Cohort 2
Participants receive multiple pulsed focused ultrasound treatments using the NaviFUS System to modulate brain activity associated with drug-resistant temporal lobe epilepsy.
2 visits per week for 2 weeks (Cohort 1) or 3 weeks (Cohort 2)
Duration - Up to 3 months after the last treatment session
Participants attend safety follow-up visits to monitor adverse events, neurological and cognitive function, and overall health after the last treatment session.
3 visits over approximately 3 months
Trial Site Locations
Total: 1 location
1
The Alfred
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
C
Caitlin Roberts, Ms.
J
Jack Germaine, Mr.
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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