Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-70
SponsorXuanwu Hospital, Beijing

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

Treatment groups

5 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators