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Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03860298
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : November 13, 2020
Sponsor:
Collaborator:
Taipei Veterans General Hospital, Taiwan
Information provided by (Responsible Party):
NaviFUS Corporation

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.

Condition or disease Intervention/treatment Phase
Drug Resistant Epilepsy Epilepsy, Drug Resistant Drug Refractory Epilepsy Epilepsy, Drug Refractory Intractable Epilepsy Epilepsy, Intractable Medication Resistant Epilepsy Refractory Epilepsy Device: NaviFUS System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 17, 2019
Actual Primary Completion Date : October 14, 2020
Actual Study Completion Date : October 14, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NaviFUS System
FUS treatment for 10 minutes
Device: NaviFUS System
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 Measures :
  1. Safety and tolerability during study period using the NaviFUS System [ Time Frame: 20 days ]
    The number and severity of adverse events


Secondary Outcome Measures :
  1. Changes of iEEG [ Time Frame: 3 days post FUS treatment ]
    Changes of excitability/irritability in focal epileptogenic region and epileptogenic network of iEEG at post FUS treatment by NaviFUS System from baseline period



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients aged 20 years and older
  2. 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.
  3. Seizure frequency is countable and available at least one month prior to study.
  4. 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:

  1. Patients with concurrent active psychiatric or mood disorders that in the opinion of the investigator would interfere with participation in the study
  2. Patients have significant bleeding after SEEG implantation
  3. Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants, vagus nerve stimulation (VNS), or deep brain stimulation (DBS)
  4. The skull bone area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp
  5. Clips or other metallic implanted objects in the FUS exposure path, except shunts
  6. 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
  7. Pregnant or breast-feeding women
  8. Coexisting medical problems of sufficient severity to limit compliance with the study
  9. Known sensitivity/allergy to Magnetic Resonance Imaging (MRI) contrast agents or any of its components
  10. Use of any recreational drugs or history of drug addiction or known history of substance or alcohol abuse
  11. Patients has participated other clinical trial within 4 weeks of entering this study
  12. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860298


Locations
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Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
NaviFUS Corporation
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Hsiang-Yu Yu, M.D. Taipei Veterans General Hospital, Taiwan
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Responsible Party: NaviFUS Corporation
ClinicalTrials.gov Identifier: NCT03860298    
Other Study ID Numbers: NF-2018-01
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NaviFUS Corporation:
NaviFUS System
Focused Ultrasound
Drug Resistant Epilepsy
Intracranial Electroencephalography
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases