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RecruitingNCT07911488Updated Nov 5, 2026

The Encora X1™ in a Real World Observational Study

An observational study in Essential Tremor, sponsored by Encora, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Encora, Inc. · Observational

Updated Nov 2, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

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.

02

Conditions studied

  • Essential Tremor

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03

In context

Essential Tremor

272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 89 across 70 observational studies indexed under Essential Tremor.

Browse Essential Tremor studies →

Lead sponsor

Encora, Inc. is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Participants with a Encora X1 Prescription and Device

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, (in English only) to participate in the study

Exclusion criteria

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
36 Months
Patient registry
Yes

Groups and cohorts

  • Registry Participants

    Device: Encora X1

Interventions

  • DeviceEncora X1

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

2 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Nov 2031, 60 months later.

Of 26 observational studies under Essential Tremor, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 25. This study's planned 60 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Nov 2, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Nov 2031
CompletionEst.
Aug 2032
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Site contacts
Changed at 1 site. See the sites
Show the site
  • Encora Therapeutics · Boston, United StatesContact a•••@encoratherapeutics.com · •••5659→l•••@encoratherapeutics.com · •••8526
Nov 5, 2026
Registered
First appeared on the registry
Nov 2, 2026
Show all 2 updates
  1. Nov 5, 2026
    Site contacts Changed at 1 site. See the sites
    Show the site
    • Encora Therapeutics · Boston, United StatesContact a•••@encoratherapeutics.com · •••5659→l•••@encoratherapeutics.com · •••8526
    + 1 other change: verification date
  2. Nov 2, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07911488
Lead sponsor
Encora, Inc.
Responsible party
Sponsor
First posted
Nov 2, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Nov 2031 (estimated)
Completion
Aug 2032 (estimated)
Last update
Nov 5, 2026

Study contacts

Alexis Noyes
Contact
advocates@encoratherapeutics.com
413-529-6728
Taylor Robertson
Contact
Ann Marie Murray, MD
principal investigator · West Virginia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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