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Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy

Primary Purpose

Drug Resistant Epilepsy, Epilepsy, Drug Resistant, Drug Refractory Epilepsy

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

NaviFUS System

About this trial

This is an interventional treatment trial for Drug Resistant Epilepsy focused on measuring NaviFUS System, Focused Ultrasound, Drug Resistant Epilepsy, Intracranial Electroencephalography

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Taipei Veterans General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

NaviFUS System

Arm Description

FUS treatment for 10 minutes

Outcomes

Primary Outcome Measures

Safety and tolerability during study period using the NaviFUS System

The number and severity of adverse events

Secondary Outcome Measures

Changes of iEEG

Changes of excitability/irritability in focal epileptogenic region and epileptogenic network of iEEG at post FUS treatment by NaviFUS System from baseline period

Full Information

NCT ID

NCT03860298

First Posted

February 26, 2019

Last Updated

November 11, 2020

Sponsor

NaviFUS Corporation

Collaborators

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT03860298

Brief Title

Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy

Official Title

A Phase I, Two-stage, and Open Label Study to Evaluate the Safety and Tolerability of Using NaviFUS System in Patients With Drug Resistant Epilepsy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

June 17, 2019 (Actual)

Primary Completion Date

October 14, 2020 (Actual)

Study Completion Date

October 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NaviFUS Corporation

Collaborators

Taipei Veterans General Hospital, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This is a phase I, two-stage, prospective, open label, single center, and single-arm study. Eligible patients will be enrolled through the process of informed consent then will receive NaviFUS treatment one cycle. The time interval for each treatment cycle is 3 days, including baseline/treatment and 3 days observation. The site of the NaviFUS exposure is where the future surgery will be removed. Concomitantly use of anti-epileptic drugs (AEDs) will be monitored and recorded in the case report form (CRF). A total of six patients will be divided into two stages of recruitment, the first stage will recruit two patients, the second stage will be four patients. When the first stage is accomplished, the data and safety monitoring board (DSMB) will review the study data and provide the recommendations regarding continuation, termination, or other modifications of the study based on evaluation of observed adverse effects of the intervention. The second stage will begin to conduct after the DSMB agrees to proceed. In this clinical trial, stereo-electroencephalography (SEEG) exploration will be carried out during long-term video-EEG monitoring and excitability/irritability in focal epileptogenic region and epileptogenic network will be analyzed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Drug Resistant Epilepsy, Epilepsy, Drug Resistant, Drug Refractory Epilepsy, Epilepsy, Drug Refractory, Intractable Epilepsy, Epilepsy, Intractable, Medication Resistant Epilepsy, Refractory Epilepsy

Keywords

NaviFUS System, Focused Ultrasound, Drug Resistant Epilepsy, Intracranial Electroencephalography

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NaviFUS System

Arm Type

Experimental

Arm Description

FUS treatment for 10 minutes

Intervention Type

Device

Intervention Name(s)

NaviFUS System

Intervention Description

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).

Primary Outcome Measure Information:

Title

Safety and tolerability during study period using the NaviFUS System

Description

The number and severity of adverse events

Time Frame

20 days

Secondary Outcome Measure Information:

Title

Changes of iEEG

Description

Changes of excitability/irritability in focal epileptogenic region and epileptogenic network of iEEG at post FUS treatment by NaviFUS System from baseline period

Time Frame

3 days post FUS treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hsiang-Yu Yu, M.D.

Organizational Affiliation

Taipei Veterans General Hospital, Taiwan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

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Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy

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