Status:
NOT_YET_RECRUITING
Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy
Lead Sponsor:
Xuanwu Hospital, Beijing
Conditions:
Epilepsy (treatment Refractory)
Eligibility:
All Genders
30-70 years
Phase:
NA
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...
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 w...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 20 2025
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT06593444
Start Date
September 20 2024
End Date
September 20 2025
Last Update
September 19 2024
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