Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy

Not Applicable

Completed

• Conditions: Drug Resistant Epilepsy; Drug Refractory Epilepsy; Refractory Epilepsy; Intractable Epilepsy; Epilepsy, Intractable; Epilepsy, Drug Resistant; Epilepsy, Drug Refractory; Medication Resistant Epilepsy
• Interventions: Device: NaviFUS System

• Registration Number: NCT03860298
• Lead Sponsor: NaviFUS Corporation

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-01
• Study Start: 2019-06-17
• Status Verified: 2020-06
• Primary Completion: 2020-10-14
• Study Completion: 2020-10-14
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

1. Male or female patients aged 20 years and older
2. 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.
3. Seizure frequency is countable and available at least one month prior to study.
4. 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

1. Patients with concurrent active psychiatric or mood disorders that in the opinion of the investigator would interfere with participation in the study
2. Patients have significant bleeding after SEEG implantation
3. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, vagus nerve stimulation (VNS), or deep brain stimulation (DBS)
4. The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
5. Clips or other metallic implanted objects in the FUS exposure path, except shunts
6. 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
7. Pregnant or breast-feeding women
8. Coexisting medical problems of sufficient severity to limit compliance with the study
9. Known sensitivity/allergy to Magnetic Resonance Imaging (MRI) contrast agents or any of its components
10. Use of any recreational drugs or history of drug addiction or known history of substance or alcohol abuse
11. Patients has participated other clinical trial within 4 weeks of entering this study
12. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NaviFUS System	NaviFUS System	FUS treatment for 10 minutes

Primary Outcome Measures

Name	Time	Method
Safety and tolerability during study period using the NaviFUS System	20 days	The number and severity of adverse events

Secondary Outcome Measures

Name	Time	Method
Changes of iEEG	3 days post FUS treatment	Changes of excitability/irritability in focal epileptogenic region and epileptogenic network of iEEG at post FUS treatment by NaviFUS System from baseline period

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan