A Pilot, Open-label, Two-arm, Parallel-group Randomized Trial Study to Evaluate the Efficacy and Safety of NaviFUS™ System Neuromodulating Treatment for Patients With Drug Resistant Epilepsy
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This will be a prospective, pilot, open-label, two-arm, parallel-group, randomized study to evaluate the efficacy and safety of low-intensity focused ultrasound (LIFU) neuromodulation using NaviFUS System in patients with drug-resistant epilepsy (DRE).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Male or female patients aged over than and equal to 18 years old.
• Patients with drug-resistant epilepsy (defined as at least 3 ASM failed) and 1-4 ASM at the time of study entry.
• Epileptogenic focus (or foci) is determined by comprehensive presurgical evaluation.
• At least 4 focal-onset seizures with objectively visible or significantly disabling manifestations in the 8-week baseline and at least one seizure per month in the baseline.
• Willing and able to sign written informed consent and be able to comply with the study protocol during the study period.
Locations
Other Locations
Taiwan
Taipei Veterans General Hospital
RECRUITING
Taipei
Contact Information
Primary
Sheang-Tze Fung, Ph.D.
stfung@navifus.com
02-25860560
Backup
Arthur Lung, Ph.D.
arthur.lung@navifus.com
Time Frame
Start Date:2024-09-01
Estimated Completion Date:2027-03-31
Participants
Target number of participants:16
Treatments
Experimental: Low dose group FUS treatment
FUS treatment will be conducted with following exposure parameters:~intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2, burst length: 3 ms, duration: three consecutive 5-minute FUS exposures with two 5-minute intermission intervals.
Experimental: High dose group FUS treatment
FUS treatment will be conducted with following exposure parameters:~intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2, burst length: 3 ms, duration: three consecutive 10-minute FUS exposures with two 5-minute intermission intervals.