Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy

NaviFUS

Status

Completed

Conditions

Drug Refractory Epilepsy

Drug Resistant Epilepsy

Epilepsy, Drug Resistant

Epilepsy, Intractable

Medication Resistant Epilepsy

Intractable Epilepsy

Epilepsy, Drug Refractory

Refractory Epilepsy

Treatments

Device: NaviFUS System

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03860298

NF-2018-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

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