Nonlinear Absorber in Essential Tremor Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Tremor improvement
研究概览
简要总结
The goal of this study is to develop a non linear absorber for patients with essential tremor (ET). It 's an extern passive medical device which should improve patients tremor.
Investigators will evaluate the impact of this medical device through one clinical scale (Fahn-Tolosa-Marin) and accelerometry record. Investigators focus on motor improvement.
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
- 20 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult man or woman between 20 and 90 years old
- •Diagnosis of ET (Essential Tremor) established by a neurologist
- •ET affecting the upper limbs, associated or not with head tremor
- •Drug-resistant nature of ET (failure of beta-blockers, mysoline, benzodiazepine)
- •Affiliate to a social security or similar system
- •Having given written consent to participate in the study, free and informed.
排除标准
- •Severe comorbidity
- •ET affecting only the leader
- •Wounds on the forearm
- •Modification of treatment or surgery to manage ET, planned within 3 months following inclusion
- •Cognitive disorder known or suspected by the investigator
- •Pregnant or breastfeeding woman
- •Persons placed under guardianship, curatorship or under judicial protection
- •Persons deprived of liberty, subject to psychiatric care or admitted to a health or social establishment for purposes other than that of clinical investigation
- •Criteria for premature discharge
- •MMSE (Mini-Mental State Examination) score<24;
- •ET of the patient with frequency range not between 4 to 6 Hz or 8 to 12 Hz and/or amplitudes of movement greater than 20°.
- •modification of treatment for ET or performance of tremor surgery before the final visit;
- •withdrawal of consent or refusal to continue visits.
结局指标
主要结局
Tremor improvement
时间窗: 6 months maximum
To assess tremor improvement, investigators will use the Fahn-Tolosa-Marin rating scale. This scale allows, thanks to a score, to assess clinical and functional evaluation of the tremor. Different aspect of the tremor are evaluate like the frequency of the tremor of the head, hand, arm..etc. and the impact of the tremor on daily actions (like writing, drawing, …). This score will be assessed at Visit 1 and 2. During visit 2, the assessment will be performed before and 1 hour after wearing the device.
次要结局
- Patient satisfaction with the device measured by a specific multidimensional questionnaire(6 months maximum)
- Tremor frequency(6 months maximum)
- Tolerance to wearing the device(6 months maximum)