Evaluation of the NaviFUS System in Drug Resistant Epilepsy

Launched by GENOVATE-NAVIFUS (AUSTRALIA) PTY LTD. · Jul 7, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the NaviFUS System for patients who have drug-resistant epilepsy, specifically temporal lobe epilepsy. Drug-resistant epilepsy means that a person's seizures do not respond well to standard medications. The NaviFUS System uses focused ultrasound to target specific areas in the brain that are believed to be causing the seizures. Participants in the trial will go through a 60-day observation period to track their seizures, followed by a treatment phase lasting either 2 or 3 weeks, where they will receive two ultrasound treatments each week. After the treatment, there will be an 81-day follow-up period to monitor safety and effectiveness.

To be eligible for this trial, participants must have a diagnosis of drug-resistant temporal lobe epilepsy and experience at least six noticeable seizures during the observation period. They should also be able to complete assessments in English, either on their own or with help from a family member or caregiver. However, there are some exclusions, such as having other types of epilepsy, recent severe medical issues, or certain implanted devices that may interfere with the treatment. Overall, this study aims to determine if the NaviFUS System is a safe and effective option for managing seizures in patients who have not found relief from traditional medications.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Diagnosis of drug resistant temporal lobe epilepsy (TLE)
• • 2. Patients must experience at least four (4) observable seizures over the 60-day baseline, each on a separate day.
• • 3. Patients have focal-onset seizures with or without secondary generalization.
• • 4. Patients have had at least 24 hours video-electroencephalography (EEG) monitoring and comprehensive epilepsy evaluation confirming TLE.
• • 5. Seizure medication treatment is anticipated to remain stable during the trial, except for rescue medicines or occasional extra doses of ongoing medicines, as required.
• • 6. Patients should be capable of and willing to completing assessments and neuropsychological testing in English either alone or with the help of the study partner (where appropriate), per local guidelines. A study partner is a carer or family member of the patient.
• • 7. Patients and study partner (if applicable) who in the Investigator's opinion are reliable and able to use the seizure diary to record seizure throughout the study and are willing to comply with study procedures and visits.
• Exclusion Criteria:
• • 1. Patients who have primary generalized epilepsy or non-epileptic seizures in the last two (2) years.
• • 2. 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.
• • 3. Patients who have experienced tonic-clonic status epilepticus in the three (3) months leading up to enrollment in the study.
• • 4. 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.
• • 5. Patients with clips or other metallic implanted objects in the FUS exposure path, except shunts.
• • 6. Patients with more than thirty percent (30%) of the skull area traversed by the sonication pathway covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp at Screening.
• • 7. Patients who have a medical or surgical history of severe systemic disease(s), such as (but not limited to) coronary artery disease, myocardial infarct, progressive heart failure, uncontrolled hypertension or abnormal ECG, severe pulmonary hypertension (pulmonary artery pressure \> 90 mmHg), chronic obstructive pulmonary disease (COPD), adult respiratory distress syndrome, hepatic and renal insufficiency (ALT or AST 3 times above normal range; serum creatinine \> 1.3 mg/dL), diabetic patients with poor control of blood sugar (HbA1c \> 8.5 %) at Screening.
• • 8. History of intracranial hemorrhage.
• • 9. History of multiple strokes, or a stroke within the six (6) months prior to Screening.
• • 10. Patients with intracranial aneurysms requiring treatment or arterial venous malformations (AVMs) requiring treatment at any time.
• • 11. Presence of central nervous system (CNS) disease(s) other than epilepsy including but not limited to infections of the CNS (e.g., syphilis, Lyme disease, borreliosis, viral or bacterial meningitis/encephalitis, human immunodeficiency virus \[HIV\] encephalopathy), cerebral vascular disease, Parkinson's disease, traumatic brain injury, alcoholic encephalopathy within three (3) years prior to Screening.
• • 12. Patients with concurrent major psychiatric disorder, such as schizophrenia or bipolar disorder, severe depression, active suicidal ideation, active psychosis (excluding time-limited postictal psychosis) or psychiatric hospitalization within one (1) year before Screening.
• • 13. Prior diagnosis of cancer within the past two (2) years and evidence of continued malignancy within the past two (2) years (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ prostate cancer with normal prostate-specific antigens post resection).
• • 14. Patients who are not able or willing to tolerate the required prolonged stationary semi-supine position during treatment.
• • 15. Inability to tolerate MRI procedures or contraindication to MRI (e.g. claustrophobia, too large for MRI scanner), including, but not limited to, presence of pacemakers (with the exception of MRI-safe pacemakers), aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or other areas of the body that would contraindicate an MRI scan.
• • 16. Patients who had major surgery six (6) weeks before study enrollment or who are not fully recovered from a surgical procedure or with planned surgery during study period or within fourteen (14) days thereafter.
• • 17. Patients who have received radiofrequency thermocoagulation (RFTC) within two (2) months of Screening.