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

NCT06492720 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-04-09

No results posted yet for this study

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).

Conditions

  • Drug Resistant Epilepsy
  • Epilepsy
  • Epilepsy, Temporal Lobe
  • Seizures, Focal

Interventions

DEVICE

Focused ultrasound (FUS) treatment

The mechanism of action of FUS neuromodulation involves the activation of voltage-gated ion channels to induce temporary neuromodulation.

Sponsors & Collaborators

  • NaviFUS Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-12-31
Completion
2027-03-31

Countries

  • Taiwan

Study Locations

More Related Trials

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 NCT06492720 on ClinicalTrials.gov