Essential TremorULTRENCT06343285
Upper Limb Tremor Reduction in Essential Tremor Patients
A study testing Encora Therapeutics Tremor Reduction Device in people with Essential Tremor, run by Encora, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 22 to 80 years
- Conditions the study is for
- Essential Tremor
- What is being tested?
- Encora Therapeutics Tremor Reduction Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2024to 12 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 22 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between the ages of 22 and 80 years of age
- A diagnosis of essential tremor (definite or probable based on TRIG criteria)
- 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
- Stable tremor medications for at least 30 days prior to enrollment and the ability to maintain stable medications through the duration of the study
- Randomization Inclusion Criteria
- During the Baseline evaluation period, a median tremor score of > 2 on at least one hand as assessed by the TETRAS finger to nose task, the duck wing task, OR the Archimedes Spiral AND
- During the Baseline evaluation period, a median score of > 3 on any one of the subject-assessed items of the Bain \& Findley Activities of Daily Living Scale (BF-ADL)
Who cannot join
- Previous surgical interventions for tremor reduction on the upper limb being used for inclusion in this study (eg, thalamotomy procedure, including Stereotactic Thalamotomy, Gamma Knife Radiosurgical Thalamotomy, or focused ultrasound)
- Use of botulinum toxin for treatment to hand tremor within six months of enrollment
- Suspected or diagnosed epilepsy or other seizure disorder
- Other possible causes of tremor, including Parkinson's disease, drug-induced tremor, or dystonia
- Pregnant
- Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
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- Numbness, tingling or pain affecting the tested upper extremity (eg, suspected or confirmed peripheral neuropathy, carpal tunnel syndrome)
- Known allergy to silicone
- Subjects are unable or unwilling to comply with the protocol requirements
- Subject is part of a vulnerable population who is unable to give Informed Consent for reasons of incapacity, dementia, immaturity, adverse personal circumstances or lack of autonomy. This may include individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent.
- Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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
- Conditions
- Essential Tremor
- Being tested
- Encora Therapeutics Tremor Reduction Device
- 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 Therapeutics Tremor Reduction DeviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Sham comparator | Inactive stimulation - device is powered on, but motors are inactive and amplitude is set to 0% Receives: Device: Encora Therapeutics Tremor Reduction Device |
| Arm 2 | Active comparator | Treatment with the wearable device set to a specific dermatome, duty cycle and amplitude Receives: Device: Encora Therapeutics Tremor Reduction Device |
| Arm 3 | Active comparator | treatment with the wearable device set to frequency-match the subject's tremor, duty cycle of and amplitude are set Receives: Device: Encora Therapeutics Tremor Reduction Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the end of the 5-day treatment period in all randomization arms
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At the end of the 5-day treatment period in all randomization arms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Jan 2024
- Primary completion3 Jul 2024
- Study completion12 Nov 2024
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
- Sequential
- Model description
- Three different arms in a randomized order
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Encora, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kristi Winterfeldt, MSHS, Principal investigator, Encora Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343285
- Sponsor's protocol ID
- 20231215
- Acronym
- ULTRE
- Status last verified
- Sep 2025
- First submitted
- 26 Jan 2024
- Last updated
- 1 Oct 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Limb Tremor Reduction in Essential Tremor Patients
- ClinicalTrials.gov ID
- NCT06343285
- Acronym / sponsor ID
- ULTRE / 20231215
- Conditions
- Essential Tremor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Encora, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 2 Apr 2024 (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.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three different arms in a randomized order
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Sham comparator | Device: Encora Therapeutics Tremor Reduction DeviceInactive stimulation - device is powered on, but motors are inactive and amplitude is set to 0% |
| Arm 2 | Active comparator | Device: Encora Therapeutics Tremor Reduction DeviceTreatment with the wearable device set to a specific dermatome, duty cycle and amplitude |
| Arm 3 | Active comparator | Device: Encora Therapeutics Tremor Reduction Devicetreatment with the wearable device set to frequency-match the subject's tremor, duty cycle of and amplitude are set |
Who may qualify
- Ages
- 22 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Between the ages of 22 and 80 years of age
- A diagnosis of essential tremor (definite or probable based on TRIG criteria)
- 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
- Stable tremor medications for at least 30 days prior to enrollment and the ability to maintain stable medications through the duration of the study
Key exclusion criteria (11 listed)
- Previous surgical interventions for tremor reduction on the upper limb being used for inclusion in this study (eg, thalamotomy procedure, including Stereotactic Thalamotomy, Gamma Knife Radiosurgical Thalamotomy, or focused ultrasound)
- Use of botulinum toxin for treatment to hand tremor within six months of enrollment
- Suspected or diagnosed epilepsy or other seizure disorder
- Other possible causes of tremor, including Parkinson's disease, drug-induced tremor, or dystonia
- Pregnant
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 Therapeutics Tremor Reduction DeviceThe 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. | Device | Arm 1, Arm 2, Arm 3 |
Primary outcome
Tolerability (Rate of Subject-Assessed Comfort with Stimulation)
Time frame: At the end of the 5-day treatment period in all randomization arms
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.
Safety (Rate of Adverse Events)
Time frame: At the end of the 5-day treatment period in all randomization arms
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.
7 secondary outcomes
Bain & Findley Activity of Daily Living (BF-ADL) #2
Time frame: At the end of the 5-day treatment period in all randomization arms
BF-ADL #4
Time frame: At the end of the 5-day treatment period in all randomization arms
BF-ADL #17
Time frame: At the end of the 5-day treatment period in all randomization arms
BF-ADL #21
Time frame: At the end of the 5-day treatment period in all randomization arms
Patient Global Impression of Change (PGI-C)
Time frame: At the end of the 5-day treatment period in all randomization arms
Clinician Global Impression of Change (CGI-C)
Time frame: At the end of the 5-day treatment period in all randomization arms
Tremor power as measured by gyroscope
Time frame: At the end of the 5-day treatment period in all randomization arms
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 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. This study is not recruiting at the moment.
Kristi Winterfeldt, MSHS principal investigator
Encora Therapeutics
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 Therapeutics Tremor Reduction Device in people with Essential Tremor, 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 1 Oct 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability (Rate of Subject-Assessed Comfort with Stimulation) (time frame: At the end of the 5-day treatment period in all randomization arms). 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 1 Oct 2025.