Upper Limb Tremor Reduction in Essential Tremor Patients

Essential Tremor Clinical Trial

— ULTRE  

Official title:

Upper Limb Tremor Reduction in Essential Tremor Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06343285
• Other study ID #: 20231215
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Essential Tremor
• Tremor

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