Upper Limb Tremor Reduction in Essential Tremor Patients

NCT06343285 | Completed FDA Device

• 1 other identifier: 20231215
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Essential Tremor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Bain & Findley Activity of Daily Living (BF-ADL) #2

  At the end of the 5-day treatment period in all randomization arms

• BF-ADL #4

  At the end of the 5-day treatment period in all randomization arms

• BF-ADL #17

  At the end of the 5-day treatment period in all randomization arms

• BF-ADL #21

  At the end of the 5-day treatment period in all randomization arms

• Patient Global Impression of Change (PGI-C)

  At the end of the 5-day treatment period in all randomization arms

Other Outcomes (6)

• The Essential Tremor Rating Scale (TETRAS) #2.4

  At the end of the 5-day treatment period in all randomization arms

• TETRAS #2.6

  At the end of the 5-day treatment period in all randomization arms

• TETRAS #2.8

  At the end of the 5-day treatment period in all randomization arms

Study Arms (3)

Arm 1

SHAM COMPARATOR

Inactive stimulation - device is powered on, but motors are inactive and amplitude is set to 0%

Device: Encora Therapeutics Tremor Reduction Device

Arm 2

ACTIVE COMPARATOR

Treatment with the wearable device set to a specific dermatome, duty cycle and amplitude

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

Device: Encora Therapeutics Tremor Reduction Device

Interventions

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.

Arm 1; Arm 2; Arm 3

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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)
• 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
• 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

Sponsors & Collaborators

• Encora, Inc.: lead

Study Sites (1)

Encora Therapeutics

Cambridge, Massachusetts, 02139, United States

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kristi Winterfeldt, MSHS

  Encora Therapeutics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization schedule maintained by non-Clinical personnel
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Three different arms in a randomized order

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: April 2, 2024
• Study Start: January 1, 2024
• Primary Completion: July 3, 2024
• Study Completion: November 12, 2024
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)