RecruitingNot ApplicableNCT07078422

Home Use Study of Targeted Mechanical Stimulation for Tremor Relief

Sponsor

Encora, Inc.

Enrollment

80 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Essential Tremor Parkinson's Disease

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria13

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
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 Criteria12

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.
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

Interventions

DEVICEEncora 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 vibration.