NCT06343285

Upper Limb Tremor Reduction in Essential Tremor Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Encora, Inc. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to demonstrate the safety, tolerability, and efficacy of the Encora Therapeutics Tremor Mitigation Device in subjects with upper limb tremor caused by Essential Tremor.

Detailed description

A prospective, randomized, blinded clinical trial. Subjects meeting all inclusion criteria will have five days of treatment with each of the three arms, received in a randomized order. Subjects will complete two rounds of assessments each day. Arm 1: Inactive stim Arm 2: Stim therapy utilizing a specific dermatome Arm 3: Stim therapy utilizing a tailored frequency

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DEVICE	Encora Therapeutics Tremor Reduction Device	The proposed therapeutic device uses vibration motors positioned around the wrist that provide on-demand-therapy to suppress resting, postural, or action tremors of the hand.

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-07-03
• Completion: 2024-11-12
• First posted: 2024-04-02
• Last updated: 2025-10-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study