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

Plain Language Summary

Simplified for easier understanding

This study is testing a wearable home device that uses gentle mechanical vibration to the wrist to reduce tremor (shaking) in people with essential tremor or Parkinson's disease. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with either essential tremor (ET) or Parkinson's disease (PD) - You have moderate to severe tremor in your arm or hand - You are mentally able to give informed consent and follow study procedures **You may NOT be eligible if...** - You are pregnant - You have swelling, infection, open wounds, or skin conditions (e.g., psoriasis, eczema) at the device's stimulation site on the wrist - You have peripheral neuropathy in the upper limbs (e.g., diabetic neuropathy, carpal tunnel syndrome) - You are unable to communicate with the study team Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.