An interventional study of Encora Therapeutics Tremor Reduction Device in Essential Tremor, sponsored by Encora, Inc.. Completed at 1 site in United States. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-10-01.
Sponsored by Encora, Inc. · Not applicable, Interventional, and Treatment
This study is designed to demonstrate the safety, tolerability, and efficacy of the Encora Therapeutics Tremor Mitigation Device in subjects with upper limb tremor caused by Essential Tremor.
A prospective, randomized, blinded clinical trial. Subjects meeting all inclusion criteria will have five days of treatment with each of the three arms, received in a randomized order. Subjects will complete two rounds of assessments each day.
Arm 1: Inactive stim Arm 2: Stim therapy utilizing a specific dermatome Arm 3: Stim therapy utilizing a tailored frequency
272 studies on the registry are indexed under Essential Tremor; 75 are open to participants now.
This study's enrollment of 71 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/Exclusion:
Inclusion Criteria:
Randomization Inclusion Criteria
Exclusion Criteria:
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.
Inactive stimulation - device is powered on, but motors are inactive and amplitude is set to 0%
Device: Encora Therapeutics Tremor Reduction Device
Treatment with the wearable device set to a specific dermatome, duty cycle and amplitude
Device: Encora Therapeutics Tremor Reduction Device
treatment with the wearable device set to frequency-match the subject's tremor, duty cycle of and amplitude are set
Device: Encora Therapeutics Tremor Reduction Device
The proposed therapeutic device uses vibration motors positioned around the wrist that provide on-demand-therapy to suppress resting, postural, or action tremors of the hand.
Tolerability (Rate of Subject-Assessed Comfort with Stimulation)
The rate of subject-assessed comfort with stimulation, on a Subject Stimulation Tolerance Questionnaire as measured by % of patient who tolerated the treatment either none of the time, some of the time or all of the time.
Time frame: At the end of the 5-day treatment period in all randomization arms
Safety (Rate of Adverse Events)
The rate of occurrence of adverse events (AEs) as both total numbers of AEs experienced throughout the study and percentage of subjects who experienced an AE.
Time frame: At the end of the 5-day treatment period in all randomization arms
Bain & Findley Activity of Daily Living (BF-ADL) #2
Use a spoon to drink soup: assess ability to perform task, score ranges from 1 (without difficulty) to 4 (cannot do by yourself).
Time frame: At the end of the 5-day treatment period in all randomization arms
BF-ADL #4
Pour milk from a carton: assess ability to perform task, score ranges from 1 (without difficulty) to 4 (cannot do by yourself).
Time frame: At the end of the 5-day treatment period in all randomization arms
BF-ADL #17
Dial a telephone: assess ability to perform task, score ranges from 1 (without difficulty) to 4 (cannot do by yourself).
Time frame: At the end of the 5-day treatment period in all randomization arms
BF-ADL #21
Insert an electric plug into a socket: assess ability to perform task, score ranges from 1 (without difficulty) to 4 (cannot do by yourself).
Time frame: At the end of the 5-day treatment period in all randomization arms
Patient Global Impression of Change (PGI-C)
Measures change in condition as compared to baseline, score ranges from 1 = Very much improved to 7 = Very much worse.
Time frame: At the end of the 5-day treatment period in all randomization arms
Clinician Global Impression of Change (CGI-C)
Measures change in condition as compared to baseline, score ranges from 1 = Very much improved to 7 = Very much worse.
Time frame: At the end of the 5-day treatment period in all randomization arms
Tremor power as measured by gyroscope
Objective, sensor-based metric for tremor measurement.
Time frame: At the end of the 5-day treatment period in all randomization arms
The Essential Tremor Rating Scale (TETRAS) #2.4
The performance section of TETRAS has 9 items rated 0-4 and a maximum total score of 64. Item 4 is comprised of 3 tasks (Extended Arm, Duck Wing, Finger-to-Nose) related to upper limb tremor, with a score ranging from 0-12.
Time frame: At the end of the 5-day treatment period in all randomization arms
TETRAS #2.6
The performance section of TETRAS has 9 items rated 0-4 and a maximum total score of 64. Item 6 is the Archimedes Spiral task, with a score ranging from 0-4.
Time frame: At the end of the 5-day treatment period in all randomization arms
TETRAS #2.8
The performance section of TETRAS has 9 items rated 0-4 and a maximum total score of 64. Item 6 is the Dot Approximation task, with a score ranging from 0-4.
Time frame: At the end of the 5-day treatment period in all randomization arms
Patient Global Impression of Severity (PGI-S)
Rating of condition severity in the past week, with score ranges from 1 = Minimal to 5 = Very Severe.
Time frame: At the end of the 5-day treatment period in all randomization arms
Clinician Global Impression of Severity (CGI-S)
Rating of condition severity in the past week, with score ranges from 1 = Minimal to 5 = Very Severe.
Time frame: At the end of the 5-day treatment period in all randomization arms
Tremor power as measured by accelerometer
Objective, sensor-based metric for tremor measurement.
Time frame: At the end of the 5-day treatment period in all randomization arms
Plan to share: No
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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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