An interventional study of NaviFUS System in Epilepsy, Temporal Lobe and Drug Resistant Epilepsy, sponsored by Genovate-NaviFUS (Australia) Pty Ltd.. Recruiting at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Genovate-NaviFUS (Australia) Pty Ltd. · Not applicable, Interventional, and Treatment
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.
Up to 30% of patients with epilepsy are resistant to current anti-seizure medications, i.e. drug-resistant epilepsy (DRE). Resective surgery of the epileptogenic regions is the most effective option to treat patients with DRE. Unfortunately, up to 60% of DRE patients are not suitable for resective surgery.
Neuromodulation approaches are increasingly being utilized in patients with DRE. The current approved techniques use invasive neuromodulation, which require complex neurosurgery and could cause side effects, such as infection, bleeding, and non-target brain tissue damage.
Focused ultrasound is a novel, noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with epilepsy. NaviFUS System (a neuro-navigation guided focused ultrasound system) is one of the FUS technologies that uses low-intensity focused ultrasound (LIFU) phased array system to deliver transcranial burst-mode ultrasound energy to induce neuromodulation effect and block signals in a specific area of the brain that cause symptoms of epilepsy such as seizures. The pilot clinical study has demonstrated that NaviFUS System safely delivered LIFU to the seizure onset zone and modulated the neuronal activity.
65 studies on the registry are indexed under Epilepsy, Temporal Lobe; 25 are open to participants now.
This study's planned enrollment of 18 is close to the median of 20 across 38 interventional studies indexed under Epilepsy, Temporal Lobe.
Browse Epilepsy, Temporal Lobe studies →This is the only study on the registry with Genovate-NaviFUS (Australia) Pty Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Eligible patients in Cohort 1 will receive two (2) FUS treatments per week for two (2) weeks on Day 1, 4, 8 and 11, followed by three (3) safety follow-up visits on Day 36, 64 and 92.
Device: NaviFUS System
Eligible patients in Cohort 2 will receive two (2) FUS treatments per week for three (3) weeks on Day 1, 4, 8, 11, 15 and 18, followed by three (3) safety follow-up visits on Day 43, 71 and 99.
Device: NaviFUS System
NaviFUS 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).
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 session
Incidence of treatment discontinuation due to AEs and SAEs
Time frame: Up to 3 months after the last treatment session
Incidence of clinically significant abnormal findings from physical and neurologic examinations
Time frame: Up to 3 months after the last treatment session
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 session
Incidence of 12-lead electrocardiogram (ECG) with clinically significant abnormal findings
Time frame: Up to 3 months after the last treatment
Incidence of Magnetic Resonance Imaging (MRI) with clinically significant abnormal findings
This outcome will be measured at Baseline Visit and 3 months after the last treatment session.
Time frame: Up to 3 months after the last treatment session
Clinically significant changes in cognitive functions from baseline assessed by Boston Naming Test-Second Edition (BNT-2)
BNT-2 is a 60-item/picture test to assess the ability to name common objects, with scores ranging from 0 to 60. Higher scores indicate better naming ability.
Time frame: Up to 3 months after the last treatment session
Clinically significant changes in cognitive functions from baseline assessed by Auditory Naming Test (ANT)
ANT is a 50-item test requiring participants to name a specific item to a description, with scores ranging from 0 to 50. Higher scores indicate better naming ability.
Time frame: Baseline Visit and 3 months after the last treatment session
Clinically significant changes in cognitive functions from baseline assessed by Sentence Repetition Test (SRT)
SRT tests immediate memory for sentences of increasing length (1-26 syllables), with scores ranging from 0 to 22. Higher scores indicate better performance.
Time frame: Baseline Visit and 3 months after the last treatment session
Clinically significant changes in cognitive functions from baseline assessed by Controlled Oral Word Association Test (COWAT)
COWAT is an oral fluency test in which the participant is required to make verbal associations to different letters of the alphabet by saying as many words as they can think of beginning with a given letter. Greater number of words produced indicates better performance on the test.
Time frame: Baseline Visit and 3 months after the last treatment session
Clinically significant changes in cognitive functions from baseline assessed by Wechsler Memory Scale-4 (WMS-4)
WMS-IV measures the ability to learn and remember information presented verbally and visually, with scores ranging from 60 to 140 (mean = 100; standard deviation = 15). Higher scores indicate better performance.
Time frame: Baseline Visit and 3 months after the last treatment session
Clinically significant changes in cognitive functions from baseline assessed by Rey Auditory Verbal Learning Test (RAVLT)
RAVLT is a test using a 15-word list to assess non-verbal learning and memory, with scores ranging from 0 to 15. Higher scores indicate better performance.
Time frame: Baseline Visit and 3 months after the last treatment session
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 session
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 session
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 session
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 session
Exploratory outcome 5: Change in frequency of interictal epileptiform discharges or electrographic seizures on 24 hour ambulatory electroencephalogram (aEEGs) from baseline
This outcome will be measured at Baseline Visit, and 1, 2, and 3 months after the last treatment session.
Time frame: Baseline Visit and 3 months after the last treatment session
Exploratory outcome 6: Change in the 31-item Quality of Life in Epilepsy (QOLIE-31) assessment from baseline
The QOLIE-31 includes 31 questions about epilepsy patient's health and daily activities, yielding a composite score from 0 to 100. Higher scores indicate a better quality of life. This outcome will be assessed at Baseline Visit, and 1, 2, and 3 months after the last treatment session.
Time frame: Baseline Visit and 3 months after the last treatment session
Exploratory outcome 7: Change in Beck Anxiety Inventory (BAI) assessment from baseline
BAI contains 21 questions, each answer being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms. This outcome will be assessed at Baseline Visit, and 1, 2, and 3 months after the last treatment session.
Time frame: Baseline Visit and 3 months after the last treatment session
Exploratory outcome 8: Change in Beck Depression Inventory-2 (BDI-2) assessment from baseline
BDI-2 consists of 21 questions, and a value of 0 to 3 is assigned for each answer, ranging in intensity. Higher total scores indicate more severe depressive symptoms. This outcome will be assessed at Baseline Visit, and 1, 2, and 3 months after the last treatment session.
Time frame: Baseline Visit and 3 months after the last treatment session
Plan to share: No
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