Refractory Epilepsy Clinical Trial
Official title:
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
Verified date | June 2020 |
Source | NaviFUS Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | October 14, 2020 |
Est. primary completion date | October 14, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Veterans General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
NaviFUS Corporation | Taipei Veterans General Hospital, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety and tolerability during study period using the NaviFUS System | The number and severity of adverse events | 20 days | |
Secondary | 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 |
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