Drug Resistant Epilepsy, Epilepsy, Drug Resistant, Drug Refractory Epilepsy, Epilepsy, Drug Refractory, Intractable Epilepsy, Epilepsy, Intractable, Medication Resistant Epilepsy, Refractory Epilepsy
Conditions
Keywords
NaviFUS System, Focused Ultrasound, Drug Resistant Epilepsy, Intracranial Electroencephalography
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.
Interventions
DEVICENaviFUS System
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).
Sponsors
Taipei Veterans General Hospital, Taiwan
NaviFUS Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and tolerability during study period using the NaviFUS System | 20 days | The number and severity of adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Taiwan
Outcome results
None listed