Evaluation of the NaviFUS System in drug resistant epilepsy
An open-label, non-randomized, single-arm pilot study to evaluate the safety and efficacy of multiple pulsed focused ultrasound treatment in patients with drug resistant temporal lobe epilepsy
Genovate-NaviFUS (Australia) Pty Ltd
18 participants
Oct 2, 2023
Interventional
Conditions
Summary
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 (FUS) 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. Participants in this study will receive FUS treatment with the NaviFUS System, guided by the neuronavigation system. During the treatment, the FUS will electronically scan and target to the assigned zones on one or both of the hippocampi. Briefly, 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
Plain Language Summary
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Interventions
Investigational Device: 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). The NaviFUS System consists of three major parts: 1. the Cabinet 2. the Console - computer device with 21.5-inch LCD monitor 3. the Exposure head with a coupling membrane attached to it – the component sits on the patient’s head to deliver FUS The NaviFUS System does not contain medicinal substances, human, or animal tissues or their derivatives, or other biologically active substances. Duration of Study: The study consists of two (2) cohorts. The only difference between the two cohorts is the overall number of weeks of treatment (2 weeks for Cohort 1 vs. 3 weeks for Cohort 2). The study investigator will advise on which cohort the patients are enrolling into as it will depend on when the patients enter the study. The safety monitoring committee (SMC) will review all safety data for Cohort 1 and confirm that it is safe to proceed with the study before the study treatment for Cohort 2 can start. Patients will undergo a 60-day screening period (from Day -60 to Day -1) for baseline observation and assessments prior to FUS treatment. • Cohort 1: 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. • Cohort 2: 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. Method of Treatment: - The NaviFUS System will be operated by trained and qualified study investigators at the investigational site. - Intracranial spatial-peak temporal-average intensity (Ispta) ceiling level: 2.8 W/cm2 (the focused ultrasound intensity in brain area considering transcranial attenuation). - The maximum total treatment exposure duration is thirty (30) minutes per treatment region.
Locations(1)
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ACTRN12623000382673