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Behavioural Intervention

Tremor Reduction Device for Essential Tremor (ULTRE Trial)

N/A
Waitlist Available
Led By Kristi Winterfeldt, MSHS
Research Sponsored by Encora, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the end of the 5-day treatment period in all randomization arms
Awards & highlights

Summary

This trial will test if the Encora Therapeutics Tremor Mitigation Device is safe and well-tolerated by people with hand tremors due to Essential Tremor.

Who is the study for?
This trial is for individuals with upper limb tremors due to Essential Tremor. Specific eligibility criteria are not provided, but typically participants would need a confirmed diagnosis and might be required to meet certain health conditions.
What is being tested?
The study is testing the Encora Therapeutics Tremor Reduction Device's safety and how well it can reduce arm shaking in people with Essential Tremor.
What are the potential side effects?
While specific side effects are not listed, generally such devices may cause discomfort, skin irritation, or temporary increase in tremor during adaptation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the end of the 5-day treatment period in all randomization arms
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of the 5-day treatment period in all randomization arms for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety
Tolerability
Secondary study objectives
BF-ADL #17
BF-ADL #21
BF-ADL #4
+3 more
Other study objectives
Clinician Global Impression of Severity (CGI-S)
Patient Global Impression of Severity (PGI-S)
TETRAS #2.6
+1 more

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Arm 3Active Control1 Intervention
treatment with the wearable device set to frequency-match the subject's tremor, duty cycle of and amplitude are set
Group II: Arm 2Active Control1 Intervention
Treatment with the wearable device set to a specific dermatome, duty cycle and amplitude
Group III: Arm 1Placebo Group1 Intervention
Inactive stimulation - device is powered on, but motors are inactive and amplitude is set to 0%

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Who is running the clinical trial?

Encora, Inc.Lead Sponsor
Kristi Winterfeldt, MSHSPrincipal InvestigatorEncora Therapeutics
~0 spots leftby Sep 2024
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