Home Use Study of Targeted Mechanical Stimulation for Tremor Relief

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.

NCT Number	NCT07078422
Lead Sponsor	Encora, Inc.
Conditions	Essential Tremor, Parkinson's Disease
Enrollment	80 participants
Start Date	2025-01-01
Primary Completion	2025-12 (estimated)
Study Completion	2026-06 (estimated)
Updated on ClinicalTrials.gov	2025-11-24