This will be a prospective, open-label, single-arm, multi-center, pilot study to evaluate the safety, tolerability, and preliminary efficacy of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy (DR-TLE).
Male or female patients ≥ 18 years of age at the time of enrollment.
Patients with drug-resistant temporal lobe epilepsy (DR-TLE), defined as failure of adequate trials of two tolerated, appropriately chosen and used anti-epileptic drug schedules (whether as monotherapies or in combination).
Focal-onset seizures with or without secondary generalization and no more than two known seizure onset zones (seizure foci), at least one which is in the mesial temporal lobe.
At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure per month in the baseline.
Patients who have primary generalized epilepsy, mixed focal and generalized epilepsy, or any history of non-epileptic seizures.
Patients who have experienced tonic-clonic status epilepticus in the 12 months before the time of enrollment in the study. Subjects with focal status epilepticus may be considered at the discretion of the Investigator.
Skull area is covered by previous surgical site(s), scars, scalp disorders (e.g., eczema, psoriasis), or scalp atrophy.
Clips or other metallic implanted objects in the skull or brain, except shunts.
Single group
NaviFUS System
DeviceFUS treatment will be conducted with following exposure parameters: intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2, burst length: 3 ms, duration: max. three consecutive 10-minute FUS exposures with two 5-minute intermission intervals.
Adverse events (AEs)
The incidence and severity of AEs associated with LIFU neuromodulation in patients with drug-resistant unilateral or bilateral temporal lobe epilepsy.
Change from baseline in seizure frequency
The changes in patient's seizure frequency during and after treatment will be assessed based on the seizure diaries.
Change from baseline in electroencephalography (EEG) epileptiform discharges
The change in patient's epileptiform discharges after treatment will be assessed based on the EEG recording.
Days of seizure-free
The changes in number of seizure-free days after FUS treatment(s).
Changes from baseline in Beck Anxiety Inventory (BAI)
BAI is a 21-question multiple-choice self-report inventory that is used to measure the severity of anxiety. Each answer is scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms.
Change from baseline in subjective seizure strength
The changes in patient's seizure strength during and after treatment will be assessed based on the seizure diaries.
Click on the lead sponsor to view all of their trials.
NaviFUS Corporation
Lead sponsor
NaviFUS US LLC
Collaborator
