Essential TremorNCT07911488
The Encora X1™ in a Real World Observational Study
An observational study of Essential Tremor, run by Encora, Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Encora X1
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to Aug 2032
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a Encora X1 Prescription and Device
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taylor Robertson contact
United States1 site, 1 recruiting
- Recruiting
Encora Therapeutics
Boston, Massachusetts, 02210
Allison Davanzo, 774-436-5659, alli@encoratherapeutics.com
Ann Maire Murray, MD
About this study
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
- Being tested
- Encora X1
- Medical subject headings
- Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Encora X1Device
Encora X1 is indicated to aid in the relief of hand tremors in the treated limb during stimulation in adults with essential tremor.
| Study group | Role | What they receive |
|---|---|---|
| Registry Participants | Not described Receives: Device: Encora X1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Bain & Findley Activities of Daily Living (BF-ADL) composite score at each scheduled assessment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 36 months
Assessment of participant overall experience with the Encora X1™ device through Patient Experience Survey.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 1, Months 1, 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completionNov 2031 (estimated)
- Study completionAug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- Encora, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann Marie Murray, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911488
- Sponsor's protocol ID
- 20262581
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Encora X1™ in a Real World Observational Study
- ClinicalTrials.gov ID
- NCT07911488
- Acronym / sponsor ID
- 20262581
- Conditions
- Essential Tremor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Encora, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Nov 2031 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Registry Participants | – | Device: Encora X1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with a Encora X1 Prescription and Device
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Encora X1Encora X1 is indicated to aid in the relief of hand tremors in the treated limb during stimulation in adults with essential tremor. | Device | Registry Participants |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Taylor Robertson contact
Ann Marie Murray, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Essential Tremor, run by Encora, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexis Noyes (413-529-6728, advocates@encoratherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.