To evaluate the performance of automatic stimulation mode of a new rechargeable implantable vagus nerve stimulation system for drug-refractory epilepsy
The study is a prospective, single-group, open-lable trial designed to collect data on patients implanted with a Model G114R VNS system (Beijing PINS Medical) from baseline through an EMU (epilepsy monitoring unit) stay of up to 5 days, and 3-mouth follow-up. The seizure burden and quality of life were evaluated. Adverse events were recorded during the trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
All patients treated with Rechargeable Implantable Vagus Nerve Stimulation System (G114R)
Peking University First Hospital
Beijing, Beijing Municipality, China
RECRUITINGSensitivity of epilepsy detection
Sensitivity is defined as the total number of seizures detected divided by the total number of seizures during the EMU stay.
Time frame: 2-4 weeks after implant
False positives for epilepsy detection
A false positive event is defined when the IPG judged a seizure and triggered automatic mode stimulation ±2 minutes outside the time window of a actual seizure. The ratio of the total number of false positive events for all subjects to the monitoring time for all subjects during the EMU phase is defined as the false positive rate.
Time frame: 2-4 weeks after implant
Changes in Seizure Frequency from Baseline
Seizure frequency is calculated at 2 and 3 month follow-up visits based on seizure diary information and compared to baseline estimates. Response rate is computed and summarized for seizure as the percentage of patients that achieved ≥50% seizure reduction per month from baseline by visit.
Time frame: up to 3 months Visit
Change in seizure Severity
The Epilepsy Severity Scale (NHS3) will be completed at baseline,at the end of the EMU phase and during the follow-up period. The severity of epilepsy will be assessed based on seizure type. The range of NHS3 scale is 1-27 with 1 being the least severe and 27 being the most severe.
Time frame: up to 3 months Visit
Change in Quality of Life
Quality of life data is collected using patient-completed QOLIE-31 scales and compared between baseline and follow-up visits. The range for QOLIE-31-P (all subscores) is 0-100 with higher scores reflecting greater well-being.
Time frame: up to 3 months Visit
Heart rate recording accuracy
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The total number and accuracy of heart rate detected by IPG are measured by ECG recording.
Time frame: 1 to 2 weeks after implantation
Duty cycle
The total percentage of time VNS is on for an individual patient is called the duty cycle. It's calculated as (ON time + X )/(ON time + OFF time), X depended on the setting of Soft start/stop.
Time frame: up to 3 months Visit
Charging Equipment Satisfaction Evaluation
A questionnaire is used to evaluate the simplicity of the charging process and overall satisfaction.
Time frame: 2-4 weeks after implant