Tests focused ultrasound for drug resistant epilepsy in adults
Tests focused ultrasound brain treatment in adults with epilepsy that medicines do not control.
Plain-language title generated from the registry record
Registry title: A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
Key facts
- Where
- Taipei, TaiwanSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06492720, who can take part
Where in Taiwan
- Taipei Veterans General HospitalTaipei, TaiwanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- NaviFUS Corporation
- Trial code
- NCT06492720
- Record updated
- 9 April 2026
- Original description
This will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant epilepsy (DRE).Read full original descriptionShow less
A Pilot, Open-label, Two-arm, Parallel-group Randomized Trial Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
This will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant epilepsy (DRE).
Inclusion: Male or female patients aged over than and equal to 18 years old; Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry; Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation; At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure per month in the baseline; Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.
Exclusion: Patients with concurrent active psychiatric or mood disorders that have been assessed to interfere with participation in the study; Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS); Patients have received an investigational drug or an investigational device within 4 weeks prior to the study; Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period); Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screening period); The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), wounds, or atrophy of the scalp; Known sensitivity/allergy to Magnetic Resonance Imaging (MRI) contrast agents or any of its components; having metallic implants that are assessed as unsuitable for MRI examination; Use of any recreational drugs or history of drug addiction or known history of substance or alcohol abuse; 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; Any other condition that, in the investigator's judgment, patient not applicable to participate this study; Abnormal coagulation profile:; Platelet (PLT) < 100,000/μL; prothrombin time (PT) > 15 sec; activated partial thromboplastin time (APTT) > 45 sec; international normalized ratio (INR) > 1.5; Patients requiring anticoagulant medications; Image documented calcified lesion in the FUS exposure path; Pregnant or breast-feeding women; Coexisting medical problems of sufficient severity to limit compliance with the study; Any ASM treatment change during the baseline (screening period); Patient has an IQ < 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-III or IV).