Back to resultsNaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
Primary Purpose
Drug Resistant Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
NaviFUS System
Sponsored by
About this trial
This is an interventional treatment trial for Drug Resistant Epilepsy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Any ASM treatment change during the baseline (screening period)
- Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period).
- Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screening period).
- Any other condition that, in the investigator's judgment, patient not applicable to participate this study.
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
FUS treatment
Sham treatment
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Safety during study period using the NaviFUS™ System in drug resistant epilepsy patients
The number and severity of adverse events
Secondary Outcome Measures
Seizure frequency
seizure diary will be utilized during long-term (two months) home monitoring and the recording will be analyzed.
Responder rate
seizure diary will be utilized during long-term (two months) home monitoring and the recording will be analyzed.
Quality of Life in Epilepsy (QOLIE-31)
A survey of health-related quality of life with epilepsy.
Number of seizure-free days
seizure diary will be utilized during long-term (two months) home monitoring and the recording will be analyzed.
Beck Anxiety Inventory (BAI)
common symptoms of anxiety
Beck Depression Inventory (BDI)
To survey patient's feeling
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04999046
Brief Title
NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
Official Title
A Pilot, Single Blind, Randomized Crossover Study to Evaluate the Safety and Efficacy of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NaviFUS Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the safety and efficacy of using NaviFUS™ system in patients with drug resistant epilepsy
Detailed Description
This is a pilot, single blind, randomized crossover design, and single center. DRE patients with a determined epileptogenic foci will be enrolled. After completing the informed consent, patients will enter the 28-day screening period for baseline observation. Patients who had at least 3 seizures during the screening period will be eligible to participate the clinical trial. Eligible patients will be randomized into two groups to receive Sham treatment or FUS treatment on day 1. After FUS/Sham treatment, patients will be under home monitor to record the seizure by daily diary card for 1 month. After 1 month (Day 30±7), patients will be crossed over to the other treatment. Another one month observation will be necessary. In this trial, patients will totally receive 2 treatments: one FUS treatment, and one Sham treatment. Sixty (±7) days after day 1, patients will have a follow-up visit and overall evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug Resistant Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FUS treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham treatment
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
NaviFUS System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety during study period using the NaviFUS™ System in drug resistant epilepsy patients
Description
The number and severity of adverse events
Time Frame
up to 2 months
Secondary Outcome Measure Information:
Title
Seizure frequency
Description
seizure diary will be utilized during long-term (two months) home monitoring and the recording will be analyzed.
Time Frame
up to 2 months
Title
Responder rate
Description
seizure diary will be utilized during long-term (two months) home monitoring and the recording will be analyzed.
Time Frame
up to 2 months
Title
Quality of Life in Epilepsy (QOLIE-31)
Description
A survey of health-related quality of life with epilepsy.
Time Frame
up to 2 months
Title
Number of seizure-free days
Description
seizure diary will be utilized during long-term (two months) home monitoring and the recording will be analyzed.
Time Frame
up to 2 months
Title
Beck Anxiety Inventory (BAI)
Description
common symptoms of anxiety
Time Frame
up to 2 months
Title
Beck Depression Inventory (BDI)
Description
To survey patient's feeling
Time Frame
up to 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Any ASM treatment change during the baseline (screening period)
Vagus nerve stimulation (VNS) dosing changes within 2 months before baseline (screening period).
Radiofrequency thermocoagulation (RFTC) within 2 months before baseline (screening period).
Any other condition that, in the investigator's judgment, patient not applicable to participate this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruby Lin, Master
Phone
(886)2-25860560
Ext
167
Email
ruby.lin@navifus.com
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsiang-Yu Yu, MD
Phone
886228757580
Email
alicehyyu@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
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