An interventional study of Encora Pulse in Essential Tremor and Parkinson's Disease, sponsored by Encora, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-24.
Sponsored by Encora, Inc. · Not applicable, Interventional, and Treatment
Subjects will receive prototype devices to be used for participation. The study comprises three phases:
272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.
This study's planned enrollment of 80 is above the median of 25 across 189 interventional studies indexed under Essential Tremor.
Browse Essential Tremor studies →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.
Inclusion Criteria - Alpha and Beta Phase B1
Exclusion Criteria - Alpha and Beta Phase B1
Inclusion Criteria - Beta Phase B2
Exclusion Criteria - Beta Phase B2
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.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Oder of assessment begins with TETRAS and ends with ADLs
Device: Encora Pulse
Order of assessment begins with ADLs and ends with TETRAs
Device: Encora Pulse
Order of assessment begins with TETRAS and ends with ADLs, but both are administered backwards
Device: Encora Pulse
Order of assessment begins with ADLs and ends with TETRAs, but both are administered backwards
Device: Encora Pulse
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.
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
Time frame: 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
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 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.
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
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.
Time frame: Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2025 (actual). Primary completion is estimated for Dec 2025, 11 months after the start.
Of 95 interventional studies with no phase under Essential Tremor, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 93. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
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Encora, Inc.