Home Use Study of Targeted Mechanical Stimulation for Tremor Relief
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Assess the design changes between the alpha and beta versions of the device
研究概览
简要总结
Subjects will receive prototype devices to be used for participation. The study comprises three phases:
- Alpha phase: Two remote study visits and an in-home period to gather device usability data on the alpha system. The at home period for this phase will be 2 weeks. This phase will be used to confirm that the device and labeling are suitable for in-home use.
- Beta Phase B1: Beta Phase B1 will be conducted using the beta devices for two in-person or remote, 60 to 90-minute, visits. This phase will be used to assess design changes between alpha and beta versions.
- Beta Phase B2: Seven remote visits and in-home usage to gather usability and efficacy data on the beta system in-home. Beta Phase B2 will be conducted using the beta devices for 12 weeks. This phase will be used to assess design changes between alpha and beta versions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Alpha and Beta Phase B1
- •Age 18 years or older, able to comply with all study procedures and capable of providing informed consent.
- •Mentally competent to understand and able to perform written, informed consent to participate in the study
- •A diagnosis of either ET or PD as determined by clinical history
- •Moderate to severe upper limb tremor
排除标准
- •Alpha and Beta Phase B1
- •Pregnant women
- •Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
- •History of psoriasis, eczema or atopic dermatitis at the stimulation site
- •History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and diabetic neuropathy
- •Participant unable to communicate with sponsor/investigator and staff
- •Any other medical conditions or physical or mental impairments that in the sponsor/investigator's opinion would render the subject unsuitable as a candidate for the study.
- •Inclusion Criteria - Beta Phase B2
- •Age 18 years or older, able to comply with all study procedures and capable of providing informed consent
- •Mentally competent to understand and able to perform written, informed consent to participate in the study
- •For ET subjects, a diagnosis of essential tremor defined as definite or probable ET based on TRIG criteria
- •For PD subjects, a diagnosis of Parkinson's disease by a Movement Disorder Specialist
- •For ET subjects, at least one hand exhibiting tremor > 2 as assessed by the Essential Tremor Rating Assessment Scale (TETRAS) finger to nose task, duck wing task, OR Archimedes Spiral completed during the Screening visit
- •For PD subjects, a score > 2 on at least one of MDS-UPDRS items 3.15, 3.16 or 3.17 At the Screening Visit, a score of > 3 on one of the following subject-assessed items of the Bain & Findley Activities of Daily Living Scale (BF-ADL): Use a spoon to drink soup, Hold a cup of tea, Do up buttons, Do up a zipper, Write a letter
- •Stable medications for at least 30 days prior to enrollment and the ability to maintain tremor medications throughout the duration of study participation
- •For PD subjects, able to participate in visits in a practically defined OFF state (withdrawal from all tremor medication for 12 hours prior to study visits)
- •A wrist circumference of 6.0 - 8.1 inches
- •Exclusion Criteria - Beta Phase B2
- •Pregnant women
- •Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
- •History of psoriasis, eczema or atopic dermatitis at the stimulation site
- •History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and -diabetic neuropathy
- •Participant unable to communicate with sponsor/investigator and staff
- •Any other medical conditions or physical or mental impairments that in the sponsor/investigator's opinion would render the subject unsuitable as a candidate for the study
研究组 & 干预措施
A
Oder of assessment begins with TETRAS and ends with ADLs
干预措施: Encora Pulse (Device)
B
Order of assessment begins with ADLs and ends with TETRAs
干预措施: Encora Pulse (Device)
C
Order of assessment begins with TETRAS and ends with ADLs, but both are administered backwards
干预措施: Encora Pulse (Device)
D
Order of assessment begins with ADLs and ends with TETRAs, but both are administered backwards
干预措施: Encora Pulse (Device)
结局指标
主要结局
Assess the design changes between the alpha and beta versions of the device
时间窗: Data will be collected at baseline and visit one.
This outcome measure assesses participants' experiences through an open-ended survey. Participants will be asked to describe their perceptions, symptoms, and overall experiences with the treatment. No predefined responses are given, and answers will be analyzed qualitatively
Assess the design changes between the alpha and beta versions of the device
时间窗: Data will be collected at baseline and visit one.
This outcome measure assesses participants' experiences through an open-ended survey. Participants will be asked to describe their perceptions, symptoms, and overall experiences with the treatment. No predefined responses are given, and answers will be analyzed qualitatively
To assess the usability of the beta device in an at-home setting
时间窗: Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.
Characterization of any unforeseen errors during subject interaction with the packaging device and instructions for use during at-home use will be collected using the usability survey which is an open ended, qualitative survey that measures patient usage error and device related satisfaction
次要结局
- To establish the quantitative efficacy in upper limb tremor reduction using the BF-ADL scale(Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.)
- To establish the quantitative efficacy in upper limb tremor reduction using the TETRAS scale(Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.)
- To establish the quantitative efficacy in upper limb tremor reduction using the BF-ADL scale(Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.)
- To establish the quantitative efficacy in upper limb tremor reduction using the TETRAS scale(Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.)