The Efficacy and Safety of Thalamic Ventral Intermediate Electrical Stimulation for Refractory Familial Cortical Myoclonus with Epilepsy: a Prospective, Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 5
- 主要终点
- Severity of Tremors
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Severity of Tremors
时间窗: 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.
次要结局
- Seizure Responder Rate(Up to 3 months after Thalamic Ventral Intermediate-DBS)
- Life quality evaluation(Up to 3 months after Thalamic Ventral Intermediate-DBS)
研究者
Liankun_Ren
Professor
Xuanwu Hospital, Beijing