A Prospective, Single-Center, Single-Arm, Open-Label Clinical Study Evaluating the Long-Term Safety and Efficacy of Transcutaneous Afferent Patterned Stimulation (TAPS) in Patients With Essential Tremor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Tremor Severity (The Essential Tremor Rating Assessment Scale [TETRAS] Score)
研究概览
简要总结
This is a prospective, single-center, single-arm, open-label clinical study designed to evaluate the long-term efficacy and safety of non-invasive neuromodulation using transcutaneous afferent patterned stimulation (TAPS) in patients with essential tremor (ET).
Essential tremor is a common movement disorder that can significantly impair daily functioning and quality of life. Pharmacological treatments are often limited by suboptimal efficacy or adverse effects, highlighting the need for alternative therapeutic approaches.
In this study, eligible participants with essential tremor will receive TAPS treatment over a defined follow-up period. Clinical outcomes, including tremor severity, functional performance, and patient-reported outcomes, will be assessed longitudinally to evaluate treatment effectiveness. Safety will be monitored throughout the study by recording adverse events and device-related complications.
The results of this study aim to provide clinical evidence regarding the long-term therapeutic potential and safety profile of TAPS as a non-invasive neuromodulation strategy for 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 and <75 years
- •Clinical diagnosis of essential tremor (ET), characterized by postural and/or kinetic tremor, primarily affecting one or both upper limbs, with or without involvement of other body regions (e.g., head, voice, or lower limbs)
- •At least one major hand task score ≥2 on the TETRAS (The Essential Tremor Rating Assessment Scale), and a score ≥3 on the Bain & Findley Activities of Daily Living (BF-ADL) scale
- •Able and willing to provide written informed consent
排除标准
- •Presence of implanted electronic medical devices (e.g., deep brain stimulator or cardiac pacemaker)
- •History of thalamotomy or other neurosurgical procedures for tremor
- •History of epilepsy
- •Current treatment with botulinum toxin for upper limb tremor
- •Skin lesions on the upper limb at the stimulation site (e.g., tumors, hemangiomas)
- •Neurological disorders affecting the upper limbs
- •Known allergy to device materials (e.g., silicone, cotton textiles)
- •Pregnant women
- •Intake of caffeine or excessive alcohol within 8 hours prior to enrollment
- •Severe cardiovascular or cerebrovascular diseases, or other significant neurological disorders
- •Inability to comply with study procedures or follow-up
研究组 & 干预措施
TAPS Treatment
干预措施: Transcutaneous Afferent Patterned Stimulation (Device)
结局指标
主要结局
Change in Tremor Severity (The Essential Tremor Rating Assessment Scale [TETRAS] Score)
时间窗: Baseline; Day 1; 1 month; 3 months
Change in tremor severity from baseline to each post-treatment time point, assessed using the The Essential Tremor Rating Assessment Scale (TETRAS). The TETRAS score ranges from 0 to 64, with higher scores indicating more severe tremor.
Incidence of Adverse Events
时间窗: 3 months
Incidence, type, and severity of adverse events occurring after treatment initiation. Adverse events will be graded according to standard criteria (e.g., CTCAE)
次要结局
- Change in Activities of Daily Living (Blessed Functional Activities of Daily Living [BF-ADL] Score)(Baseline; Day 1; 1 month; 3 months)
- Change in Anxiety Severity (Hamilton Anxiety Rating Scale [HAMA])(Baseline; 1 month; 3 months)
- Change in Depression Severity (Hamilton Depression Rating Scale [HAMD])(Baseline; 1 month; 3 months)
- Change in Cognitive Function (Montreal Cognitive Assessment [MoCA])(Baseline; 1 month; 3 months)
- Change in Cognitive Function (Mini-Mental State Examination [MMSE])(Baseline; 1 month; 3 months)
- Change in EEG Alpha Band Power(Baseline; 1 month; 3 months)
- Change in Motor Evoked Potential (MEP) Amplitude(Baseline; 1 month; 3 months)
- Change in Functional Connectivity (fMRI)(Baseline; 3 months)