NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy

NCT04999046 | Completed

• 1 other identifier: NF-2021-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Epilepsy; Seizure; Seizure Disorder; Drug Resistant Epilepsy

Keywords

focused ultrasound; LIFU; NaviFUS System

Outcome Measures

Primary Outcomes (1)

• Safety during study period using the NaviFUS™ System in drug resistant epilepsy patients

  The number and severity of adverse events

  up to 2 months

Secondary Outcomes (6)

• Seizure frequency

  up to 2 months

• Responder rate

  up to 2 months

• Quality of Life in Epilepsy (QOLIE-31)

  up to 2 months

• Number of seizure-free days

  up to 2 months

• Beck Anxiety Inventory (BAI)

  up to 2 months

Study Arms (2)

FUS treatment

EXPERIMENTAL

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. The FUS exposure area will be the epileptogenic focus which is individually different and determined by standard clinical practice previously.

Device: NaviFUS System

Sham treatment

SHAM COMPARATOR

Sham treatment is to mimic the FUS treatment procedure but without any energy. The ISPTA will be 0 W/cm2, duration: three repeating 5-minute sham exposures with two 5-minute intermission intervals.

Device: NaviFUS System

Interventions

NaviFUS System DEVICE

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.

FUS treatment; Sham treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged ≥20 years old.
• Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.
• An epileptogenic foci is determined by comprehensive presurgical evaluation
• Seizure number is countable and had been recorded at least 6 times within 2-month in medical history before screening period.
• Seizure number had been recorded at least 3 times within 28-day screening period.
• 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 in the opinion of the investigator would 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), or atrophy of the scalp.
• Clips or other metallic implanted objects in the FUS exposure path, except shunts.
• Abnormal coagulation profile:
• Platelet (PLT) \< 100,000/μL.
• prothrombin time (PT) \>14 sec.
• activated partial thromboplastin time (APTT) \>36 sec.
• and international normalized ratio (INR) \> 1.3.
• 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.
• 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.

Sponsors & Collaborators

• NaviFUS Corporation: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy; Seizures; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 10, 2021
• Study Start: October 7, 2021
• Primary Completion: May 13, 2024
• Study Completion: July 31, 2024
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)