Status:
COMPLETED
Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy
Lead Sponsor:
NaviFUS Corporation
Collaborating Sponsors:
Taipei Veterans General Hospital, Taiwan
Conditions:
Drug Resistant Epilepsy
Epilepsy, Drug Resistant
Eligibility:
All Genders
20+ years
Phase:
NA
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 treatme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2020
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03860298
Start Date
June 17 2019
End Date
October 14 2020
Last Update
November 13 2020
Active Locations (1)
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1
Taipei Veterans General Hospital
Taipei, Taiwan, 11217