NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy (NCT04999046) | Clinical Trial Compass
CompletedNot Applicable
NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
Taiwan12 participantsStarted 2021-10-07
Plain-language summary
To evaluate the safety and efficacy of using NaviFUS™ system in 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 old.
. Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.
. An epileptogenic foci is determined by comprehensive presurgical evaluation
. Seizure number is countable and had been recorded at least 6 times within 2-month in medical history before screening period.
. Seizure number had been recorded at least 3 times within 28-day screening period.
. Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.
Exclusion criteria
. Patients with concurrent active psychiatric or mood disorders that in the opinion of the investigator would interfere with participation in the study.
. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, 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.
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
1
Safety during study period using the NaviFUS™ System in drug resistant epilepsy patients