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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
NaviFUS System
DeviceNaviFUS System (Neuronavigation-Guided Focused Ultrasound System) is a new non-invasive device, which uses the neuronavigation principle to guide focused ultrasound (FUS) energy precisely delivering through the skull to selected brain tissues without surgery in real-time. In this clinical study, the NaviFUS System is intended to deliver low intensity FUS to generate neuromodulation effects on a predetermined treatment region (one or both of the hippocampi which are associated with seizure), for the treatment for drug-resistant temporal lobe epilepsy (TLE).
Treatment groups
18 Participants
are divided into 2 treatment groupsGroup A: Cohort 1Experimental treatment 1 intervention
Group B: Cohort 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence, nature and severity of adverse events (AEs), serious adverse events (SAEs) and AE of special interest (seizures, headaches, mental state changes, language and memory changes, lethargy/fatigue, and nausea)
This outcome will be assessed through the review of medical records and participant self-reporting in seizure diary.
Time frame
Up to 3 months after the last treatment session2
Incidence of treatment discontinuation due to AEs and SAEs
Time frame
Up to 3 months after the last treatment session3
Incidence of clinically significant abnormal findings from physical and neurologic examinations
Time frame
Up to 3 months after the last treatment session4
Incidence of clinically significant abnormal vital sign measurements, and abnormal vital signs reported as AEs and SAEs
Time frame
Up to 3 months after the last treatment sessionOther outcomes
1
Exploratory outcome 1: Change in seizure frequency after FUS treatment compared to baseline
This outcome will be assessed through the review of medical records and participant self-reporting in seizure diary.
Time frame
From Baseline Visit until 3 months after the last treatment session2
Exploratory outcome 2: Responder rate (defined as at least 50% seizure reduction)
This outcome will be assessed through the review of medical records and participant self-reporting in seizure diary.
Time frame
From Baseline Visit until 3 months after the last treatment session3
Exploratory outcome 3: Percentage change in days seizure-free
This outcome will be assessed through the review of medical records and participant self-reporting in seizure diary.
Time frame
From Baseline Visit until 3 months after the last treatment session4
Exploratory outcome 4: Subjective scoring of seizure intensity
This outcome will be assessed through the review of medical records and participant self-reporting in seizure diary. The seizure intensity (severity) will be scored on a 7-point scale of 1 (very mild) to 7 (very severe).
Time frame
From Baseline Visit until 3 months after the last treatment sessionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Genovate-NaviFUS (Australia) Pty Ltd.
Lead sponsor
Genovate Biotechnology Co., Ltd.,
Collaborator
NaviFUS Corporation
Collaborator
Source ClinicalTrials.gov