Back to search results

Home Use Study of Encora Pulse for Tremor Relief

This study is testing a device called Encora Pulse, a wristband that delivers personalized mechanical vibrations to help relieve tremors. It's designed for people aged 18 or older who have Essential Tremor or Parkinson's Disease with moderate to severe upper limb tremor. The main goal is to see how well the beta version of the device works and how easy it is to use in a home setting. The study will also compare design changes between earlier and later versions of the device. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 80 participants. It involves three phases to test different versions of the device.
What's involved
You would receive prototype devices to use at home. This involves remote and potentially in-person visits, with at-home usage periods lasting 2 weeks in the alpha phase and 12 weeks in the beta phase.
Compensation
Not stated in the trial record.
Follow-up
Usability of the beta device will be assessed at baseline, week 1, week 2, month 1, month 2, and month 3.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07078422

Home Use Study of Targeted Mechanical Stimulation for Tremor Relief

Recruiting
NAAges 18+InterventionalTreatment
Encora, Inc.
~80 participants
Updated 2025-11-24 on ClinicalTrials.gov
What's tested:Encora Pulse

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess the design changes between the alpha and beta versions of the device
Measured over Data will be collected at baseline and visit one.
+1 more outcome measured

Conditions

Essential Tremor
Parkinson's Disease

Explore related trials

Essential TremorParkinson Disease

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Ann Marie Murray, MD · PRINCIPAL_INVESTIGATOR · WVU Comprehensive Movement Disorder Clinic

Who to contact

Allison Davanzo
[email protected]
855-937-5302
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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
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

Exclusion

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.
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

What this trial measures

  • Assess the design changes between the alpha and beta versions of the deviceData 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 settingData 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