Epilepsy (treatment Refractory)
Conditions
Keywords
Deep Brain Stimulation, Thalamic Ventral Intermediate, Refractory Familial Cortical Myoclonus with Epilepsy
Brief summary
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.
Detailed description
This project aims to include 5 participants, and evaluate the effectiveness and safety of Thalamic Ventral Intermediate electrical stimulation in patients with refractory familial cortical myoclonus with epilepsy through a prospective, interventional, unblinded, single-arm clinical trial. It is expected to provide new therapeutic options for patients with refractory familial cortical myoclonus with epilepsy with alternative treatment options.
Interventions
PROCEDUREThalamic Ventral Intermediate-DBS
Participants 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.
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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. * Willing to adhere to the relevant trial protocol and regulations, including attending follow-up visits and undergoing related examinations within the specified timeframe.
Exclusion criteria
* 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. * Pregnant individuals or those planning to conceive within 2 years. * Presence of progressive neurological diseases such as brain tumors, arteriovenous malformations, or cavernous hemangiomas. * Presence of other serious neuropsychiatric disorders such as dementia, severe depression (hospitalized in a psychiatric facility within the past 5 years or any suicidal or self-harming tendencies), schizophrenia, or neurodegenerative diseases. Resolved postictal psychiatric or behavioral abnormalities are not an exclusion criterion. * Conditions that may increase the risk of seizures during or after surgery (e.g., coagulation disorders) or require long-term oral anticoagulants or antiplatelet drugs. * Other severe physical illnesses, psychiatric disorders, internal diseases, or severe liver or kidney dysfunction; participation in other clinical trials within the past three months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of Tremors | Up to 3 months after Thalamic Ventral Intermediate-DBS | A difference in tremor severity before and after treatment according to the TETRAS scale has been observed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seizure Responder Rate | Up to 3 months after Thalamic Ventral Intermediate-DBS | The proportion of patients with a ≥ 50% reduction from Baseline in seizure frequency. |
| Life quality evaluation | Up to 3 months after Thalamic Ventral Intermediate-DBS | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Up to 3 months after Thalamic Ventral Intermediate-DBS | Rate of adverse events which were judged to be study-related throughout the study. |
| Serious Adverse Event | Up to 3 months after Thalamic Ventral Intermediate-DBS | Rate of serious adverse events which were judged to be study-related throughout the study. |
| Incidence of Sudden Unexpected Death in Epilepsy (SUDEP) | Up to 3 months after Thalamic Ventral Intermediate-DBS | The number presented is for Definite and Probable SUDEP. The rate is calculated per 1000 subject years of follow-up. |
Contacts
Primary ContactLiankun Ren
Outcome results
None listed