CompletedNot Applicable

Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy

Taiwan6 participantsStarted 2019-06-17

Plain-language 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.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety and tolerability during study period using the NaviFUS System

Timeframe: 20 days

Trial details

NCT IDNCT03860298

SponsorNaviFUS Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-10-14

View on ClinicalTrials.gov More Drug Resistant Epilepsy trials