A Pilot Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy

Recruiting now · Not applicable

Conditions studied: Drug Resistant Epilepsy, Epilepsy, Epilepsy, Temporal Lobe, Seizures, Focal

In brief

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).

Key facts

Study ID

NCT06492720

Run by

NaviFUS Corporation

People needed

16

Starts

2024-09-01

Expected to finish

2027-03-31

Last updated by the study team

2026-04-09

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).
• The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), wounds, or atrophy of the scalp.
• Image documented calcified lesion in the FUS exposure path.
• 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.
• Pregnant or breast-feeding women.
• Coexisting medical problems of sufficient severity to limit compliance with the study.
• 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.
• Patients have received an investigational drug or an investigational device within 4 weeks prior to the study
• 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 ASM treatment change during the baseline (screening period).
• Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period).
• Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screening period).
• Patient has an IQ < 70, based on the Wechsler Abbreviated Scale of Intelligence (WASI-III or IV).
• Any other condition that, in the investigator's judgment, patient not applicable to participate this study.

Where it is running

• Taipei Veterans General Hospital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.