NCT06492720 A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
| NCT ID | NCT06492720 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NaviFUS Corporation |
| Condition | Drug Resistant Epilepsy |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2024-09-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 16 participants in total. It began in 2024-09-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: 1. Male or female patients aged over than and equal to 18 years old. 2. Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry. 3. Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation. 4. 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. 5. Willing and able to sign written informed consent and be able to comply with the study protocol during the study period. Exclusion Criteria: 1. Patients with concurrent active psychiatric or mood disorders that have been assessed to interfere with participation in the study. 2. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, or deep brain stimulation (DBS). 3. The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), wounds, or atrophy of the scalp. 4. Image documented calcified lesion in the FUS exposure path. 5. Abnormal coagulation profile: 1. Platelet (PLT) \< 100,000/μL. 2. prothrombin time (PT) \> 15 sec. 3. activated partial thromboplastin time (APTT) \> 45 sec. 4. international normalized ratio (INR) \> 1.5. 5. Patients requiring anticoagulant medications. 6. Pregnant or breast-feeding women. 7. Coexisting medical problems of sufficient severity to limit compliance with the study. 8. 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. 9. Use of any recreational drugs or history of drug addiction or known history of substance or alcohol abuse. 10. Patients have received an investigational drug or an investigational device within 4 weeks prior to the study 11. 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. 12. Any ASM treatment change during the baseline (screening period). 13. Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period). 14. Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screening period). 15. Patient has an IQ \< 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-III or IV). 16. Any other condition that, in the investigator's judgment, patient not applicable to participate this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06492720 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Drug Resistant Epilepsy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06492720 currently recruiting?
Yes, NCT06492720 is actively recruiting participants. Contact the research team at stfung@navifus.com for enrollment information.
Where is the NCT06492720 trial being conducted?
This trial is being conducted at Taipei, Taiwan.
Who is sponsoring the NCT06492720 clinical trial?
NCT06492720 is sponsored by NaviFUS Corporation. The trial plans to enroll 16 participants.
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