Actively Recruiting
A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
Led by NaviFUS Corporation · Updated on 2026-04-09
16
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older
- Drug-resistant epilepsy defined as failure of at least 3 anti-seizure medications
- Currently taking 1 to 4 anti-seizure medications at study entry
- Epileptogenic focus identified by comprehensive presurgical evaluation
- At least 4 focal-onset seizures with clear symptoms during an 8-week baseline
- At least one seizure per month during baseline
- Able and willing to provide written informed consent and comply with study procedures
You will not qualify if you...
- Active psychiatric or mood disorders that interfere with study participation
- Presence of pacemaker, implantable cardioverter-defibrillator, permanent medication pumps, cochlear implants, or deep brain stimulation
- Scars, scalp disorders, wounds, or scalp atrophy along the ultrasound path
- Calcified lesions detected in the focused ultrasound exposure path
- Abnormal blood clotting profiles including low platelets, prolonged prothrombin time, activated partial thromboplastin time, or elevated INR
- Use of anticoagulant medications
- Pregnancy or breastfeeding
- Severe medical problems limiting study compliance
- Allergy or sensitivity to MRI contrast agents or unsuitability for MRI due to metallic implants
- Use of recreational drugs, history of drug addiction, or substance/alcohol abuse
- Participation in another investigational drug or device study within 4 weeks before this study
- Any anti-seizure medication changes during the 8-week baseline period
- Changes in vagus nerve stimulation dosing within 2 months before baseline
- Radiofrequency thermocoagulation within 2 months before baseline
- IQ below 70 based on Wechsler Abbreviated Scale of Intelligence
- Any other condition judged by the investigator to affect study results or patient safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
S
Sheang-Tze Fung, Ph.D.
CONTACT
A
Arthur Lung, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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