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NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy

NCT04999046 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-04-09

No results posted yet for this study

Summary

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

Conditions

  • Drug Resistant Epilepsy
  • Seizure
  • Seizure Disorder
  • Epilepsy

Interventions

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.

Sponsors & Collaborators

  • NaviFUS Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-07
Primary Completion
2024-05-13
Completion
2024-07-31

Countries

  • Taiwan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04999046 on ClinicalTrials.gov