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Evaluation of the NaviFUS System in Drug Resistant Epilepsy
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2023-10-02
Primary completion: 2025-05-01
Study completion finish: 2025-05-01
Study type
TREATMENT
Phase
NA
Trial ID
NCT05947656
Intervention or treatment
DEVICE: NaviFUS System
Conditions
- • Epilepsy, Temporal Lobe
- • Drug Resistant Epilepsy
Find a site
Closest Location:
The Alfred
Research sites nearby
Select from list below to view details:
The Alfred
Melbourne, Victoria, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Cohort 1
| DEVICE: NaviFUS System
|
EXPERIMENTAL: Cohort 2
| DEVICE: NaviFUS System
|
What is the study measuring?
Primary outcome
| Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
|---|---|---|
| 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. | Up to 3 months after the last treatment session |
| Incidence of treatment discontinuation due to AEs and SAEs | Not Specified | Up to 3 months after the last treatment session |
| Incidence of clinically significant abnormal findings from physical and neurologic examinations | Not Specified | 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 | Not Specified | Up to 3 months after the last treatment session |
| Incidence of 12-lead electrocardiogram (ECG) with clinically significant abnormal findings | Not Specified | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Baseline Visit and 3 months after the last treatment session |
Secondary outcome
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