Essential TremorNCT07078422
Home Use Study of Targeted Mechanical Stimulation for Tremor Relief
A study testing Encora Pulse in people with Essential Tremor and Parkinson's Disease, run by Encora, Inc. at 1 site in United States.
Trial summary
Subjects will receive prototype devices to be used for participation. The study comprises three phases: 1. Alpha phase: Two remote study visits and an in-home period to gather device usability data on the alpha system. The at home period for this phase will be 2 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor, Parkinson's Disease
- What is being tested?
- Encora Pulse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to Jun 2026
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years or older, able to comply with all study procedures and capable of providing informed consent.
- Mentally competent to understand and able to perform written, informed consent to participate in the study
- A diagnosis of either ET or PD as determined by clinical history
- Moderate to severe upper limb tremor
- Age 18 years or older, able to comply with all study procedures and capable of providing informed consent
- Mentally competent to understand and able to perform written, informed consent to participate in the study
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- For ET subjects, a diagnosis of essential tremor defined as definite or probable ET based on TRIG criteria
- For PD subjects, a diagnosis of Parkinson's disease by a Movement Disorder Specialist
- For ET subjects, at least one hand exhibiting tremor > 2 as assessed by the Essential Tremor Rating Assessment Scale (TETRAS) finger to nose task, duck wing task, OR Archimedes Spiral completed during the Screening visit
- For PD subjects, a score > 2 on at least one of MDS-UPDRS items 3.15, 3.16 or 3.17 At the Screening Visit, a score of > 3 on one of the following subject-assessed items of the Bain \& Findley Activities of Daily Living Scale (BF-ADL): Use a spoon to drink soup, Hold a cup of tea, Do up buttons, Do up a zipper, Write a letter
- Stable medications for at least 30 days prior to enrollment and the ability to maintain tremor medications throughout the duration of study participation
- For PD subjects, able to participate in visits in a practically defined OFF state (withdrawal from all tremor medication for 12 hours prior to study visits)
- A wrist circumference of 6.0 - 8.1 inches
Who cannot join
- Pregnant women
- 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
- Participant unable to communicate with sponsor/investigator and staff
- Any other medical conditions or physical or mental impairments that in the sponsor/investigator's opinion would render the subject unsuitable as a candidate for the study.
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- Pregnant women
- 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
- Participant unable to communicate with sponsor/investigator and staff
- Any other medical conditions or physical or mental impairments that in the sponsor/investigator's opinion would render the subject 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.
United States1 site, 1 recruiting
- Recruiting
Encora Therapeutics
Cambridge, Massachusetts, 02142
Allison Davanzo, 855-937-5302, alli@encoratherapeutics.com
About this study
Subjects will receive prototype devices to be used for participation. The study comprises three phases:
- Alpha phase: Two remote study visits and an in-home period to gather device usability data on the alpha system. The at home period for this phase will be 2 weeks. This phase will be used to confirm that the device and labeling are suitable for in-home use.
- Beta Phase B1: Beta Phase B1 will be conducted using the beta devices for two in-person or remote, 60 to 90-minute, visits. This phase will be used to assess design changes between alpha and beta versions.
- Beta Phase B2: Seven remote visits and in-home usage to gather usability and efficacy data on the beta system in-home. Beta Phase B2 will be conducted using the beta devices for 12 weeks. This phase will be used to assess design changes between alpha and beta versions.
- Conditions
- Essential Tremor, Parkinson's Disease
- Being tested
- Encora Pulse
- 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 PulseDevice
The proposed therapeutic device is a wristband that delivers personalized therapeutic relief to users by adjusting parameters of mechanical vibration, tailored to each individual user's tremor. It measures and characterizes users' upper limb tremor before determining what parameters of mechanical vibration should be applied to stimulate the sensory neurons on the wrist.
This study will not be conducted under IDE. It is a non-significant risk due to the non-invasive nature of mechanical vibration.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Oder of assessment begins with TETRAS and ends with ADLs Receives: Device: Encora Pulse |
| B | Experimental | Order of assessment begins with ADLs and ends with TETRAs Receives: Device: Encora Pulse |
| C | Experimental | Order of assessment begins with TETRAS and ends with ADLs, but both are administered backwards Receives: Device: Encora Pulse |
| D | Experimental | Order of assessment begins with ADLs and ends with TETRAs, but both are administered backwards Receives: Device: Encora Pulse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the design changes between the alpha and beta versions of the device
This outcome measure assesses participants' experiences through an open-ended survey. Participants will be asked to describe their perceptions, symptoms, and overall experiences with the treatment. No predefined responses are given, and answers will be analyzed qualitatively
Measured: Data will be collected at baseline and visit one.
To assess the usability of the beta device in an at-home setting
Characterization of any unforeseen errors during subject interaction with the packaging device and instructions for use during at-home use will be collected using the usability survey which is an open ended, qualitative survey that measures patient usage error and device related satisfaction
Measured: Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.
Secondary outcomes (2)
To establish the quantitative efficacy in upper limb tremor reduction using the BF-ADL scale
The Bain and Findley Tremor ADL Scale (BF-ADL) is a tool used to assess the impact of essential tremor on a person's ability to perform activities of daily living (ADLs), specifically those involving the upper limbs. The effectiveness of the device in reducing limb tremor will be evaluated using the BF-ADL scale. The scale rates each activity on a 1-to-4 scale: 1 indicates the activity can be done without difficulty, 2 with little effort, 3 with a lot of effort, and 4 means the activity cannot be done alone.
Measured: Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.
To establish the quantitative efficacy in upper limb tremor reduction using the TETRAS scale
The effectiveness of the device in reducing limb tremor will be evaluated using the TETRAS (Tremor Research Group Essential Tremor Rating Assessment Scale) tool. Tremor severity will be measured on a scale of 0 to 4; a score of 0 indicates no tremor, while a score of 4 represents severe tremor. Scores between 0 and 4 can be assigned using increments of 0.5, allowing for a more nuanced assessment of tremor severity.
Measured: Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start1 Jan 2025
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study design is modeled after a typical movement assessment, relevant to the diagnosis, and modified to apply the treatment. Participants will perform movements typical of the motor assessments both before and during treatment. The intent of the study is to confirm the device design and usability in the subject's home environment. The study will also measure change in treatment effect after long periods of regular use.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Encora, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann Marie Murray, MD, Principal investigator, WVU Comprehensive Movement Disorder Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07078422
- Sponsor's protocol ID
- 20232333
- Status last verified
- Jul 2025
- First submitted
- 9 Apr 2025
- Last updated
- 24 Nov 2025
- 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 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Use Study of Targeted Mechanical Stimulation for Tremor Relief
- ClinicalTrials.gov ID
- NCT07078422
- Acronym / sponsor ID
- 20232333
- Conditions
- Essential Tremor, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Encora, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 22 Jul 2025 (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.
Subjects will receive prototype devices to be used for participation. The study comprises three phases:
- Alpha phase: Two remote study visits and an in-home period to gather device usability data on the alpha system. The at home period for this phase will be 2 weeks. This phase will be used to confirm that the device and labeling are suitable for in-home use.
- Beta Phase B1: Beta Phase B1 will be conducted using the beta devices for two in-person or remote, 60 to 90-minute, visits. This phase will be used to assess design changes between alpha and beta versions.
- Beta Phase B2: Seven remote visits and in-home usage to gather usability and efficacy data on the beta system in-home. Beta Phase B2 will be conducted using the beta devices for 12 weeks. This phase will be used to assess design changes between alpha and beta versions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- The study design is modeled after a typical movement assessment, relevant to the diagnosis, and modified to apply the treatment. Participants will perform movements typical of the motor assessments both before and during treatment. The intent of the study is to confirm the device design and usability in the subject's home environment. The study will also measure change in treatment effect after long periods of regular use.
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Encora PulseOder of assessment begins with TETRAS and ends with ADLs |
| B | Experimental | Device: Encora PulseOrder of assessment begins with ADLs and ends with TETRAs |
| C | Experimental | Device: Encora PulseOrder of assessment begins with TETRAS and ends with ADLs, but both are administered backwards |
| D | Experimental | Device: Encora PulseOrder of assessment begins with ADLs and ends with TETRAs, but both are administered backwards |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 years or older, able to comply with all study procedures and capable of providing informed consent.
- Mentally competent to understand and able to perform written, informed consent to participate in the study
- A diagnosis of either ET or PD as determined by clinical history
- Moderate to severe upper limb tremor
- Age 18 years or older, able to comply with all study procedures and capable of providing informed consent
Key exclusion criteria (12 listed)
- Pregnant women
- 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
- Participant unable to communicate with sponsor/investigator and staff
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 PulseThe proposed therapeutic device is a wristband that delivers personalized therapeutic relief to users by adjusting parameters of mechanical vibration, tailored to each individual user's tremor. It measures and characterizes users' upper limb tremor before determining what parameters of mechanical vibration should be applied to stimulate the sensory neurons on the wrist. This study will not be conducted under IDE. It is a non-significant risk due to the non-invasive nature of mechanical vibration. | Device | A, B, C, D |
Primary outcome
Assess the design changes between the alpha and beta versions of the device
Time frame: Data will be collected at baseline and visit one.
This outcome measure assesses participants' experiences through an open-ended survey. Participants will be asked to describe their perceptions, symptoms, and overall experiences with the treatment. No predefined responses are given, and answers will be analyzed qualitatively
To assess the usability of the beta device in an at-home setting
Time frame: Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.
Characterization of any unforeseen errors during subject interaction with the packaging device and instructions for use during at-home use will be collected using the usability survey which is an open ended, qualitative survey that measures patient usage error and device related satisfaction
2 secondary outcomes
To establish the quantitative efficacy in upper limb tremor reduction using the BF-ADL scale
Time frame: Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.
To establish the quantitative efficacy in upper limb tremor reduction using the TETRAS scale
Time frame: Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.
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 24 Nov 2025.
- 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.
Ann Marie Murray, MD principal investigator
WVU Comprehensive Movement Disorder Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Encora Pulse in people with Essential Tremor and Parkinson's Disease, 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 13 inclusion and 12 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 24 Nov 2025. 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 Allison Davanzo (855-937-5302, alli@encoratherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess the design changes between the alpha and beta versions of the device (time frame: Data will be collected at baseline and visit one.). The study lists 2 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 24 Nov 2025.