Efficacy and Safety of Non-invasive Temporal Interference Stimulation in the Treatment of Essential Tremor: A Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Tremor Level Evaluation
研究概览
简要总结
This single-center prospective study aims to investigate the treatment efficacy of temporal interference (TI) in essential tremor patients aged 30-70.
详细描述
Temporal Interference (TI) technology is a novel non-invasive method for deep brain stimulation (DBS). By generating an overlapping electric field from safe currents, TI creates focused stimulation in targeted deep brain areas. This approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive DBS for clinical treatments.
This study aims to investigate the treatment efficacy of TI deep brain stimulation by including essential tremor patients aged 30-70. Before and after TI stimulation, clinical data will be recorded. Clinical and imaging data will be analyzed and processed to advance the treatment of essential tremor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 years old, regardless of gender. Action tremor and postural tremor in both upper limbs, or action tremor and postural tremor in one limb;
- •No history of mental diseases;
- •Informed consent signed.
排除标准
- •Presence of other neurological diseases affecting the study (such as epilepsy);
- •Patients with moderate to severe cognitive impairment (Montreal Cognitive Assessment ≤ 18 points);
- •Orthopedic diseases that may affect motor symptoms;
- •Patients taking antipsychotic or antidepressant medications;
- •Presence of metal implants in the body (such as brain pacemakers or cardiac pacemakers);
- •History of electroconvulsive therapy;
- •Presence of cardiovascular risk factors, etc.
结局指标
主要结局
Tremor Level Evaluation
时间窗: Up to 3 months after TI stimulation
Percentage change in per month after stimulation from baseline in The Essential Tremor Rating Assessment Scale(TETRAS) score. The TETRAS score ranges from 0 to 112, including an activities of daily living (ADL) section(0-48 scores) and a performance section(0-64 scores), with higher scores representing more severe tremor and lower scores indicating lower tremor level
次要结局
未报告次要终点
研究者
Liankun_Ren
Professor
Xuanwu Hospital, Beijing