NCT03860298

Brief Summary

This study is to evaluate the safety and the intracranial electroencephalography (iEEG) changes of using NaviFUS System for the treatment of patients with drug resistant epilepsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

June 17, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2020

Completed
Last Updated

November 13, 2020

Status Verified

June 1, 2020

Enrollment Period

1.3 years

First QC Date

February 26, 2019

Last Update Submit

November 11, 2020

Conditions

Drug Resistant EpilepsyEpilepsy, Drug ResistantDrug Refractory EpilepsyEpilepsy, Drug RefractoryIntractable EpilepsyEpilepsy, IntractableMedication Resistant EpilepsyRefractory Epilepsy

Keywords

NaviFUS SystemFocused UltrasoundDrug Resistant EpilepsyIntracranial Electroencephalography

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability during study period using the NaviFUS System

    The number and severity of adverse events

    20 days

Secondary Outcomes (1)

  • Changes of iEEG

    3 days post FUS treatment

Study Arms (1)

NaviFUS System

EXPERIMENTAL

FUS treatment for 10 minutes

Device: NaviFUS System

Interventions

NaviFUS SystemDEVICE

Using NaviFUS System treatment for 10 minutes in drug resistant epilepsy. The site of the NaviFUS exposure is where the future surgery will be removed. Patients will concomitant use of anti-epileptic drugs (AEDs).

NaviFUS System

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female patients aged 20 years and older
  • Patients with drug resistant epilepsy (have failed treatment with at least two appropriate anti-epileptic drugs (AEDs) due to lack of efficacy) who hospitalized and underwent stereo-electroencephalography (SEEG) implantation for localization and delineation of epileptogenic focus for removing by surgery.
  • Seizure frequency is countable and available at least one month prior to study.
  • Willing and able to sign written informed consent and be able to comply with the study protocol for the duration of the study

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
  • Patients have significant bleeding after SEEG implantation
  • Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, vagus nerve stimulation (VNS), 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 or 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 has participated other clinical trial within 4 weeks of entering this 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Drug Resistant Epilepsy

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hsiang-Yu Yu, M.D.

    Taipei Veterans General Hospital, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2019

First Posted

March 1, 2019

Study Start

June 17, 2019

Primary Completion

October 14, 2020

Study Completion

October 14, 2020

Last Updated

November 13, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)