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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Sham Comparator | Inactive stimulation - device is powered on, but motors are inactive and amplitude is set to 0% |
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| Arm 2 | Active Comparator | Treatment with the wearable device set to a specific dermatome, duty cycle and amplitude |
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| Arm 3 | Active Comparator | treatment with the wearable device set to frequency-match the subject's tremor, duty cycle of and amplitude are set |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Encora Therapeutics Tremor Reduction Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | At the end of the 5-day treatment period in all randomization arms |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | At the end of the 5-day treatment period in all randomization arms |
| BF-ADL #4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At the end of the 5-day treatment period in all randomization arms |
Inclusion/Exclusion:
Inclusion Criteria:
Randomization Inclusion Criteria
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristi Winterfeldt, MSHS | Encora Therapeutics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Encora Therapeutics | Cambridge | Massachusetts | 02139 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 27, 2026 | May 18, 2026 | 6 |
| ID | Term |
|---|---|
| D020329 | Essential Tremor |
| ID | Term |
|---|---|
| D009069 | Movement Disorders |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Three different arms in a randomized order
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Randomization schedule maintained by non-Clinical personnel
Pour milk from a carton: assess ability to perform task, score ranges from 1 (without difficulty) to 4 (cannot do by yourself). |
| 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). | 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). | 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. | 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. | 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. | 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. |
| 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. | 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. | 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. | 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. | At the end of the 5-day treatment period in all randomization arms |