Evaluation of the NaviFUS System in Drug Resistant Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenovate-NaviFUS (Australia) Pty Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Diagnosis of drug resistant temporal lobe epilepsy (TLE)
Patients must experience at least four (4) observable seizures over the 60-day baseline, each on a separate day.
Patients have focal-onset seizures with or without secondary generalization.
Patients have had at least 24 hours video-electroencephalography (EEG) monitoring and comprehensive epilepsy evaluation confirming TLE.
Disqualifiers
Patients who have primary generalized epilepsy or non-epileptic seizures in the last two (2) years.
More than two (2) seizure onset zones (foci) (except bitemporal foci) or unknown likely site of seizure onset, as determined by usual clinical, electroencephalography (EEG) and imaging practice.
Patients who have experienced tonic-clonic status epilepticus in the three (3) months leading up to enrollment in the study.
Presence of devices including but not limited to cardiac pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, responsive neurostimulator (RNS) or deep brain stimulation (DBS). Vagus nerve stimulators (VNS) do not represent an exclusion criterion, but settings should be stable throughout the trial.
Trial design
Treatments tested in this trial
- NaviFUS System
Treatment groups
18 Participants
are divided into 2 treatment groupsSponsors and collaborators
Genovate-NaviFUS (Australia) Pty Ltd.
Lead sponsor
Genovate Biotechnology Co., Ltd.,
Collaborator
NaviFUS Corporation
Collaborator
Source ClinicalTrials.gov