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Drug Resistant EpilepsyNCT03860298

Safety of Using NaviFUS System in Patients With Drug Resistant Epilepsy

A study testing NaviFUS System in people with Drug Resistant Epilepsy and Epilepsy, Drug Resistant, run by NaviFUS Corporation at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
What is being tested?
NaviFUS System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteTaiwan
Study dates
17 Jun 2019to 14 Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Taipei Veterans General Hospital

    Taipei, 11217

Other trials in Taiwan

About this study

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

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.

Read the 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.

Being tested
NaviFUS System
Keywords
NaviFUS System, Focused Ultrasound, Drug Resistant Epilepsy, Intracranial Electroencephalography
Medical subject headings
Drug Resistant Epilepsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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).

Study groups in NCT03860298
Study groupRoleWhat they receive
NaviFUS SystemExperimentalFUS treatment for 10 minutes
Receives: Device: NaviFUS System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability during study period using the NaviFUS System

    The number and severity of adverse events

    Measured: 20 days

Secondary outcomes (1)

  1. 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

    Measured: 3 days post FUS treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2019
  2. Study start17 Jun 2019
  3. Primary completion14 Oct 2020
  4. Study completion14 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03860298
Sponsor's protocol ID
NF-2018-01
Status last verified
Jun 2020
First submitted
26 Feb 2019
Last updated
13 Nov 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NaviFUS System in people with Drug Resistant Epilepsy and Epilepsy, Drug Resistant, run by NaviFUS Corporation at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability during study period using the NaviFUS System (time frame: 20 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03860298.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.

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