Home Use Study of Targeted Mechanical Stimulation for Tremor Relief
Condition(s) studied
Investigational drug(s) / intervention(s)
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 vibration.
Study 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
Primary outcome measure(s)
- Assess the design changes between the alpha and beta versions of the device — 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 — 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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Encora Therapeutics | Cambridge | Massachusetts | Recruiting |
More Encora, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07078422 on ClinicalTrials.gov ↗ ← All trials in the USA