What this study is
Simplified from ClinicalTrials.govStudying a wrist-worn, non-invasive device that gives mechanical stimulation to help relieve hand tremors (Encora X1), to learn how it affects daily activities and satisfaction over 36 months in adults 18 and older with essential tremor, a condition that causes shaking.
Read the original summary from ClinicalTrials.gov
This research is a post-market study designed to evaluate the long-term, real-world impact of the Encora X1™ on your daily life. The Encora X1™ is a FDA-cleared, wrist-worn, non-invasive neurostimulator device that delivers personalized mechanical stimulation to aid in the relief of hand tremors in adults with essential tremor. A non-invasive device is a device that stays outside of the body. It is not implanted and does not penetrate the skin. Neurostimulation means that the device uses targeted electrical or magnetic pulses to stimulate activity in the nervous system.
This study aims to understand how it improves your ability to perform daily activities and your overall satisfaction with the device over a 36-month period. Your feedback will help researchers understand how the device is used over a long period of time in a home environment and improve the delivery of care for individuals with Essential Tremor.
What's being tested
- Encora X1
Intervention · DEVICE
Encora X1 is indicated to aid in the relief of hand tremors in the treated limb during stimulation in adults with essential tremor.
Study details
- Sponsor
- Encora, Inc.
- Conditions
- Essential Tremor
- Enrolling
- 1,000 people
- Starts
- 2026-11-01
- Est. completion
- 2032-08
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age 18 years or older and able to comply with all study procedures
- A diagnosis of upper limb Essential Tremor (ET) as determined by clinical history
- A prescription for the Encora X1™
- Must have at least occasional access to a computer, tablet or smartphone, and be able to complete study questionnaires through the participant portal.
- Mentally competent to understand and able to perform written, informed consent (in English only) to participate in the study
You can't join if
- Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
- History of psoriasis, eczema or atopic dermatitis at the stimulation site
- History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and diabetic neuropathy
- Pregnant women, or women who plan to become pregnant during their duration of the study
- Use of other External Upper Limb Tremor Stimulation Therapy during the course of the study
- Patient unable to communicate with sponsor/investigator and study staff
- Any other medical conditions or physical or mental impairments that in the sponsor/investigator's opinion would render the participant unsuitable as a candidate for the study.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openEncora Therapeutics
Boston, Massachusetts, United States
- Lexi Noyes · Contact978-381-8526lexi@encoratherapeutics.com
- Ann Maire Murray, MD · Principal investigator
Recruiting
Study team
Sponsor
Encora, Inc.
Study ID 20262581
Principal investigator
Ann Marie Murray, MD
West Virginia University
CONTACT
Taylor Robertson
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.