NCT04999046

NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: NaviFUS Corporation · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and efficacy of using NaviFUS™ system in patients with drug resistant epilepsy

Detailed description

This is a pilot, single blind, randomized crossover design, and single center. DRE patients with a determined epileptogenic foci will be enrolled. After completing the informed consent, patients will enter the 28-day screening period for baseline observation. Patients who had at least 3 seizures during the screening period will be eligible to participate the clinical trial. Eligible patients will be randomized into two groups to receive Sham treatment or FUS treatment on day 1. After FUS/Sham treatment, patients will be under home monitor to record the seizure by daily diary card for 1 month. After 1 month (Day 30±7), patients will be crossed over to the other treatment. Another one month observation will be necessary. In this trial, patients will totally receive 2 treatments: one FUS treatment, and one Sham treatment. Sixty (±7) days after day 1, patients will have a follow-up visit and overall evaluation.

Conditions

• Drug Resistant Epilepsy
• Seizure
• Seizure Disorder
• Epilepsy

Interventions

Type	Name	Description
DEVICE	NaviFUS System	FUS treatment will be conducted with following exposure parameters: intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2 (the focused ultrasound intensity in brain area considering transcranial attenuation), burst length: 3 ms, duration: three consecutive 5-minute FUS exposures with two 5-minute intermission intervals.

Timeline

• Start date: 2021-10-07
• Primary completion: 2024-05-13
• Completion: 2024-07-31
• First posted: 2021-08-10
• Last updated: 2026-04-09

Locations

1 site across 1 country: Taiwan