Home Use Study of Targeted Mechanical Stimulation for Tremor Relief

Обзор

Subjects will receive prototype devices to be used for participation. The study comprises three phases: 1. 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. 2. 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. 3. 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.

Вмешательства

• Устройство Encora Pulse
  The proposed therapeutic device is a wristband that delivers personalized therapeutic relief to users by adjusting parameters of mechanical vibration, tailored to each individual user's tremor. It measures and characterizes users' upper limb tremor before determining what parameters of mechanical vibration should be applied to stimulate the sensory neurons on the wrist. This study will not be conducted under IDE. It is a non-significant risk due to the non-invasive nature of mechanical vibratio

Первичные конечные точки

• Assess the design changes between the alpha and beta versions of the device [Срок оценки: Data will be collected at baseline and visit one.]
• To assess the usability of the beta device in an at-home setting [Срок оценки: Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.]

Вторичные конечные точки (2)

• To establish the quantitative efficacy in upper limb tremor reduction using the BF-ADL scale [Срок оценки: 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 [Срок оценки: Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.]

Критерии участия

Inclusion Criteria - 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

Exclusion Criteria - 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Encora Therapeutics — Cambridge

Идентификаторы

NCT: NCT07078422 · 20232333

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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