Recruiting

Encora X1™

Sponsor:

Encora, Inc.

Code:

NCT07911488

Conditions

Essential Tremor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Encora X1

Study Details

Brief 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.

Conditions

Essential Tremor

Study ID

NCT07911488

Start date

Nov 1, 2026

Status verified date

Oct, 2026

Completion date

Aug, 2032

Anticipated

Primary completion date

Nov, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Registry Participants

Interventions

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.

Primary outcome measure

  • Change from baseline in the Bain & Findley Activities of Daily Living (BF-ADL) composite score at each scheduled assessment. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Up to 36 months ]
  • Assessment of participant overall experience with the Encora X1™ device through Patient Experience Survey. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Baseline to Week 1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36 ]

Central Contacts and Locations

Central contacts

Alexis Noyes

413-529-6728advocates@encoratherapeutics.com

Locations

Encora Therapeutics

Recruiting

Boston, Massachusetts, United States, 02210

Contacts

Allison Davanzo

774-436-5659alli@encoratherapeutics.com

Principal Investigator:

Ann Maire Murray, MD

More Information

Sponsor

Encora, Inc.

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by Encora, Inc. on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.