Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy

Study Overview
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Brief Summary
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This study is to evaluate the safety and the intracranial electroencephalography (iEEG) changes of using NaviFUS System for the treatment of patients with drug resistant epilepsy.

Detailed Description
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This is a phase I, two-stage, prospective, open label, single center, and single-arm study. Eligible patients will be enrolled through the process of informed consent then will receive NaviFUS treatment one cycle. The time interval for each treatment cycle is 3 days, including baseline/treatment and 3 days observation. The site of the NaviFUS exposure is where the future surgery will be removed. Concomitantly use of anti-epileptic drugs (AEDs) will be monitored and recorded in the case report form (CRF). A total of six patients will be divided into two stages of recruitment, the first stage will recruit two patients, the second stage will be four patients. When the first stage is accomplished, the data and safety monitoring board (DSMB) will review the study data and provide the recommendations regarding continuation, termination, or other modifications of the study based on evaluation of observed adverse effects of the intervention. The second stage will begin to conduct after the DSMB agrees to proceed. In this clinical trial, stereo-electroencephalography (SEEG) exploration will be carried out during long-term video-EEG monitoring and excitability/irritability in focal epileptogenic region and epileptogenic network will be analyzed.

Official Title
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A Phase I, Two-stage, and Open Label Study to Evaluate the Safety and Tolerability of Using NaviFUS System in Patients With Drug Resistant Epilepsy

Conditions
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Drug Resistant Epilepsy, Epilepsy, Drug Resistant, Drug Refractory Epilepsy, Epilepsy, Drug Refractory, Intractable Epilepsy, Epilepsy, Intractable, Medication Resistant Epilepsy, Refractory Epilepsy

Intervention / Treatment
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* Device: NaviFUS System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients aged 20 years and older Patients with drug resistant epilepsy (have failed treatment with at least two appropriate anti-epileptic drugs (AEDs) due to lack of efficacy) who hospitalized and underwent stereo-electroencephalography (SEEG) implantation for localization and delineation of epileptogenic focus for removing by surgery. Seizure frequency is countable and available at least one month prior to study. Willing and able to sign written informed consent and be able to comply with the study protocol for the duration of the study Exclusion Criteria: Patients with concurrent active psychiatric or mood disorders that in the opinion of the investigator would interfere with participation in the study Patients have significant bleeding after SEEG implantation Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, vagus nerve stimulation (VNS), or deep brain stimulation (DBS) The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp Clips or other metallic implanted objects in the FUS exposure path, except shunts Abnormal coagulation profile: Platelet (PLT) < 100,000/μL, prothrombin time (PT) >14 sec or activated partial thromboplastin time (APTT) >36 sec, and international normalized ratio (INR) > 1.3 Pregnant or breast-feeding women Coexisting medical problems of sufficient severity to limit compliance with the study Known sensitivity/allergy to Magnetic Resonance Imaging (MRI) contrast agents or any of its components Use of any recreational drugs or history of drug addiction or known history of substance or alcohol abuse Patients has participated other clinical trial within 4 weeks of entering this study Any other condition that, in the investigator's judgment, might affect study endpoints or might increase the risk to the patients or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NaviFUS System<br>FUS treatment for 10 minutes | Device: NaviFUS System<br>* Using NaviFUS System treatment for 10 minutes in drug resistant epilepsy. The site of the NaviFUS exposure is where the future surgery will be removed. Patients will concomitant use of anti-epileptic drugs (AEDs).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability during study period using the NaviFUS System | The number and severity of adverse events | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of iEEG | Changes of excitability/irritability in focal epileptogenic region and epileptogenic network of iEEG at post FUS treatment by NaviFUS System from baseline period | 3 days post FUS treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NaviFUS System, Focused Ultrasound, Drug Resistant Epilepsy, Intracranial Electroencephalography