The Encora X1™ in a Real World Observational Study

Condition(s) studied

Investigational drug(s) / intervention(s)

Encora X1: Encora X1 is indicated to aid in the relief of hand tremors in the treated limb during stimulation in adults with essential tremor.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Change from baseline in the Bain & Findley Activities of Daily Living (BF-ADL) composite score at each scheduled assessment. — Baseline to Week 1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 and Post Treatment Weeks 1, 4 and 8
• Change from baseline in the TETRAS PRO composite score at each scheduled assessment. — Baseline to Week 1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36
• Change from baseline in the QUEST PRO weighted index score at each scheduled assessment. — Baseline to Week 1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36
• Change from baseline in the EQ-5D-5L index value at each scheduled assessment. — Baseline to Week 1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36
• Change from baseline in WPAI (Work Productivity and Activity Impairment) domain scores at each scheduled assessment. — Baseline to Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36
• Change from baseline in Patient Global Impression of Severity (PGI-S) at each scheduled assessment. — Baseline to Week 1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36 and Post Treatment Weeks 1, 4 and 8
• Evaluation of participant therapy usage up to each scheduled assessment. — Baseline to Week 1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36
• Evaluation of changes in the type, frequency, or dosage of tremor-related medications during the 36-month study period. — Up to 36 months
• Assessment of participant overall experience with the Encora X1™ device through Patient Experience Survey. — Months 1, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36
• Change from baseline in each of the 25 individual Bain & Findley Activities of Daily Living (BF-ADL) item scores at each scheduled assessment. — Baseline to Week 1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36
• Change from baseline in each of the 14 individual TETRAS PRO item scores at each scheduled assessment. — Baseline to Week 1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36
• Change from baseline to each scheduled assessment timepoint in daily evaluation based metrics using tremor power from postural hold. — Baseline to Week 1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36
• Change from baseline to each scheduled assessment timepoint in daily evaluation based metrics using modified PGI-S. — Baseline to Week 1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36
• Change from baseline to each scheduled assessment timepoint in daily evaluation based metrics using modified PGI-C. — Baseline to Week 1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36

Trial sites (1)

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