The primary objective of this research is to study the efficacy and safety of deep brain stimulation (DBS) of Thalamic Ventral Intermediate as adjunctive therapy for alleviating symptoms in refractory familial cortical myoclonus with epilepsy.
Aged 30-70, meeting the diagnostic criteria for Refractory Familial Cortical Myoclonus with Epilepsy (FCMTE), meaning that tremors and/or seizures have not significantly improved despite long-term, stable use of current treatment medications, regardless of gender.
Tremors and seizures severely impact the patients' work and quality of life.
Experiencing drug resistance or intolerable adverse reactions to medication.
After being adequately informed about the nature and risks of the study, willing to provide written informed consent before participating in any study-related procedures.
Patients with FCMTE whose symptoms are essentially controlled after standardized medication and other treatments.
Presence of structural abnormalities in the VIM (ventral intermediate nucleus).
Presence of an implanted electrical stimulator (e.g., pacemaker, spinal cord stimulator, repetitive nerve stimulator) or metallic implants in the head (e.g., aneurysm clips, cochlear implants). Note: Vagus nerve stimulation (with stable parameters for at least 3 months) is not an exclusion criterion.
IQ < 55, severe cognitive impairment that prevents participation in the study.
Single group
Thalamic Ventral Intermediate-DBS
Procedure/SurgeryParticipants will undergo Thalamic Ventral Intermediate-DBS ON with the individual stimulation parameters determined in the parameter determination period, then continue to receive stimulation for the remainder of the study.
Severity of Tremors
A difference in tremor severity before and after treatment according to the TETRAS scale has been observed.
Seizure Responder Rate
The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency.
Life quality evaluation
Percentage change from baseline in Quality of Life in Epilepsy-31 inventory (QOLIE-31) score. The minimum and maximum values, and whether higher scores mean a better or worse outcome.
Adverse Events
Rate of adverse events which were judged to be study-related throughout the study.
Serious Adverse Event
Rate of serious adverse events which were judged to be study-related throughout the study.
Incidence of Sudden Unexpected Death in Epilepsy (SUDEP)
The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up.
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