About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Thalamic Ventral Intermediate-DBS