NCT07078422

Home Use Study of Targeted Mechanical Stimulation for Tremor Relief

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Encora, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Essential Tremor
• Parkinson's Disease

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-12-01
• Completion: 2026-06-01
• First posted: 2025-07-22
• Last updated: 2025-11-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study