Upper Limb Tremor Reduction in Essential Tremor Patients (ULTRE)

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.

Study Overview

• Status: Completed
• Conditions: Essential Tremor
• Intervention / Treatment: Device: Encora Therapeutics Tremor Reduction Device

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 Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02139
      • Encora Therapeutics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion/Exclusion:

Inclusion Criteria:

1. Between the ages of 22 and 80 years of age
2. A diagnosis of essential tremor (definite or probable based on TRIG criteria)
3. At least one hand exhibiting tremor > 2 as assessed by the Essential Tremor Rating
4. Assessment Scale (TETRAS) finger to nose task, duck wing task, OR Archimedes Spiral completed during the Screening visit
5. 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

1. 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
2. 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)

Exclusion Criteria:

1. 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)
2. Use of botulinum toxin for treatment to hand tremor within six months of enrollment
3. Suspected or diagnosed epilepsy or other seizure disorder
4. Other possible causes of tremor, including Parkinson's disease, drug-induced tremor, or dystonia
5. Pregnant
6. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site
7. Numbness, tingling or pain affecting the tested upper extremity (eg, suspected or confirmed peripheral neuropathy, carpal tunnel syndrome)
8. Known allergy to silicone
9. Subjects are unable or unwilling to comply with the protocol requirements
10. 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.
11. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Arm 1; Inactive stimulation - device is powered on, but motors are inactive and amplitude is set to 0%	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.
Active Comparator: Arm 2; Treatment with the wearable device set to a specific dermatome, duty cycle and amplitude	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.
Active Comparator: Arm 3; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Encora, Inc.
• Investigators: Principal Investigator: Kristi Winterfeldt, MSHS, Encora Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): July 3, 2024
• Study Completion (Actual): November 12, 2024

Study Registration Dates

• First Submitted: January 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Essential Tremor; Dermatologic Agents; Keratolytic Agents; Coal Tar
• Other Study ID Numbers: 20231215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No