To evaluate the safety and efficacy of using NaviFUS™ system in patients with drug resistant epilepsy
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
12
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.
Taipei Veterans General Hospital
Taipei, Taiwan
Safety during study period using the NaviFUS™ System in drug resistant epilepsy patients
The number and severity of adverse events
Time frame: up to 2 months
Seizure frequency
seizure diary will be utilized during long-term (two months) home monitoring and the recording will be analyzed.
Time frame: up to 2 months
Responder rate
seizure diary will be utilized during long-term (two months) home monitoring and the recording will be analyzed.
Time frame: up to 2 months
Quality of Life in Epilepsy (QOLIE-31)
A survey of health-related quality of life with epilepsy.
Time frame: up to 2 months
Number of seizure-free days
seizure diary will be utilized during long-term (two months) home monitoring and the recording will be analyzed.
Time frame: up to 2 months
Beck Anxiety Inventory (BAI)
common symptoms of anxiety
Time frame: up to 2 months
Beck Depression Inventory (BDI)
To survey patient's feeling
Time frame: up to 2 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.