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Behavioural Intervention

Arm 2 for Essential Tremor (ULTRE Trial)

N/A

Recruiting

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

ULTRE Trial 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.Check my eligibility

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.See study design

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.

ULTRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of the 5-day treatment period in all randomization arms

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety

Tolerability

Secondary outcome measures

BF-ADL #17

BF-ADL #21

BF-ADL #4

+4 more

Other outcome measures

Clinician Global Impression of Severity (CGI-S)

Patient Global Impression of Severity (PGI-S)

TETRAS #2.6

+3 more

ULTRE Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Arm 2Active Control1 Intervention

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

Group II: 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 III: Arm 1Placebo Group1 Intervention

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

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Encora, Inc.Lead Sponsor

Kristi Winterfeldt, MSHSPrincipal InvestigatorEncora Therapeutics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the eligibility criteria for participating in this clinical trial?

"To meet the criteria for participation in this medical investigation, individuals must exhibit essential tremors and fall within the age range of 22 to 80 years. This study is currently accepting approximately 30 eligible candidates."

Answered by AI

Are patients currently being enrolled in this research study?

"As stated on clinicaltrials.gov, this investigation is actively pursuing volunteers. The trial was initially disclosed on January 1st, 2024 and last revised on March 26th of the same year."

Answered by AI

Are individuals above the age of 45 eligible to participate in this study?

"Eligible participants for this research must be between 22 and 80 years old. There are separate studies available for individuals under 18 and those above 65, with a total of 56 slots allocated."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Upper Limb Tremor Reduction in Essential Tremor Patients

2024. "Upper Limb Tremor Reduction in Essential Tremor Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06343285.

All > Paid Studies Boston > Essential Tremor