Preliminary observations on the domestic closed-loop self-responsive neurostimulation system for the treatment of refractory epilepsy
Objective To explore the initial efficacy of the domestic closed-loop self-responsive neurostimulation system in the treatment of drug-resistant epilepsy.Methods Six patients with refractory epilepsy admitted to the Neurosurgery Department of the Second Affiliated Hospital of Zhejiang University School of Medicine from March 2022 to November 2022 were prospectively enrolled and treated with a closed-loop self-responsive neurostimulation system.The effectiveness and safety of the treatment were evaluated in the outpatient clinic 4,7,10,and 13 months after the start of the stimulation,including the seizure control effect,improvement in quality of life,and occurrence of adverse reactions.The seizure control effect was assessed based on the frequency,duration,and number of days with the seizures in a month.Results The operations of all 6 patients were successfully completed.Among them,4 patients were implanted with deep electrodes(2 per case)in the bilateral hippocampi,1 patient was implanted with 2 cortical electrodes in the left central cortex,and 1 patient was implanted with 1 deep electrode and 1 cortical electrodes in the left hippocampus+left temporal lobe respectively.Stimulation parameters(median)included the amplitude of 4.0 mA,frequency of 200 Hz,pulse width of 160 μs and duration of 100 ms.Five cases completed the 13-month follow-up after startup,and one case only completed the 11-month follow-up.At 10 months and 13 months follow-up after the device was turned on,the patient's seizure frequency decreased[M(Q1,Q3)]by 39％(10％,46％)and 44％(21％,49％)respectively compared with the preoperative baseline.By the last follow-up,the duration of epileptic seizures was reduced by ≤10％in 4 patients and by＞30％in 2 patients;the number of seizure days was reduced by ≤10％in 4 patients and by＞30％in 2 patients.Compared with the preoperative baseline,there were no statistically significant differences in the patients'Hamilton Depression Rating Scale,Quality of Life Scale 31,Hamilton Anxiety Rating Scale or Montreal Cognitive Assessment scores 7 months after the start of stimulation(all P＞0.05).As of the last follow-up,no surgery-or device-related adverse events occurred in any patient.Conclusion Preliminary observations indicate that treatment with a domestic closed-loop self-responsive neurostimulation system can reduce the frequency of epileptic seizures in patients with refractory epilepsy to a certain extent,and no related adverse events have been observed.
Drug resistant epilepsyElectric stimulation therapyTreatment outcomeClosed-loop neurostimulation
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