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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06343285
Other study ID # 20231215
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date June 2024

Study information

Verified date April 2024
Source Encora, Inc.
Contact Kristi Winterfeldt, MSHS
Phone 7632481210
Email kristi@encoratherapeutics.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is designed to demonstrate the safety and tolerability of the Encora Therapeutics Tremor Mitigation Device in subjects with upper limb tremor caused by Essential Tremor.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date June 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender All
Age group 22 Years to 80 Years
Eligibility 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 Assessment Scale (TETRAS) finger to nose task OR duck wing task completed during the Screening visit 4. At least one hand exhibiting tremor > 1 on the Archimedes Spiral task 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 > 2.5 on at least one hand as assessed by the TETRAS finger to nose task OR the duck wing task 2. During the Baseline evaluation period, a median score of > 3 on any one of the assessed items of the Bain & Findley Activities of Daily Living Scale (BF-ADL) Exclusion Criteria: 1. Previous thalamotomy procedure, including Stereotactic Thalamotomy, Gamma Knife Radiosurgical Thalamotomy, and focused ultrasound for tremor reduction on the upper limb being used for inclusion in this study 2. Suspected or diagnosed epilepsy or other seizure disorder 3. Other possible causes of tremor, including Parkinson's disease, drug-induced tremor, or dystonia 4. Pregnant 5. Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site 6. Peripheral neuropathy affecting the tested upper extremity 7. Known allergy to silicone 8. Subjects are unable or unwilling to comply with the protocol requirements 9. Any clinical condition that might interfere with the trial protocol or the subject's ability to be compliant with the trial protocol (e.g., active alcohol or drug abuse, dementia, etc.) 10. Subject is part of a vulnerable population who is unable to give Informed Consent for reasons of incapacity, 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Encora Therapeutics Cambridge Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Encora, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other The Essential Tremor Rating Scale (TETRAS) #2.4 At the end of the 5-day treatment period in all randomization arms
Other TETRAS #2.6 At the end of the 5-day treatment period in all randomization arms
Other TETRAS #2.8 At the end of the 5-day treatment period in all randomization arms
Other Patient Global Impression of Severity (PGI-S) At the end of the 5-day treatment period in all randomization arms
Other Clinician Global Impression of Severity (CGI-S) At the end of the 5-day treatment period in all randomization arms
Other Tremor power as measured by accelerometer At the end of the 5-day treatment period in all randomization arms
Primary Tolerability The rate of subject-assessed tolerance, on a Subject Stimulation Therapy Tolerance 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
Primary Safety 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 Bain & Findley Activity of Daily Living (BF-ADL) #2 At the end of the 5-day treatment period in all randomization arms
Secondary BF-ADL #4 At the end of the 5-day treatment period in all randomization arms
Secondary BF-ADL #17 At the end of the 5-day treatment period in all randomization arms
Secondary BF-ADL #21 At the end of the 5-day treatment period in all randomization arms
Secondary Patient Global Impression of Change (PGI-C) At the end of the 5-day treatment period in all randomization arms
Secondary Clinician Global Impression of Change (CGI-C) At the end of the 5-day treatment period in all randomization arms
Secondary Tremor power as measured by gyroscope At the end of the 5-day treatment period in all randomization arms
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