Encora Pulse for Tremor Relief

Overseen By Allison Davanzo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Encora, Inc.

Disqualifiers: Pregnancy, Skin conditions, Neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, Encora Pulse, designed to reduce tremors in people with essential tremor (ET) or Parkinson's disease (PD). The trial includes three phases to determine if the device is easy to use at home and effectively reduces tremors. Participants with moderate to severe hand tremors, who have stable medications and can stop tremor medications 12 hours before visits, might be suitable candidates. Those diagnosed with ET or PD and experiencing troublesome hand tremors should consider whether this trial is appropriate. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research and potentially benefit from innovative treatment.

Will I have to stop taking my current medications?

Participants need to have stable medications for at least 30 days before joining the study and must keep taking their tremor medications during the study. However, for Parkinson's disease subjects, they need to stop taking tremor medication for 12 hours before study visits.

What prior data suggests that the Encora Pulse device is safe for tremor relief?

Research has shown that the Encora Pulse device is safe and easy to use. In earlier studies, only 5.6% of participants experienced mild to moderate side effects, which resolved on their own without treatment. Additionally, 94% of users reported that the device was comfortable to wear. This evidence suggests that the Encora Pulse is safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Encora Pulse for tremor relief because it offers a potentially innovative approach to managing tremors. Unlike traditional treatments that rely heavily on medications like beta-blockers or anticonvulsants, Encora Pulse may provide a non-drug alternative. This method focuses on a unique assessment protocol that alternates between testing tremor severity and daily living activities in different sequences, offering insights into how different assessment orders might impact treatment effectiveness. By exploring these various assessment techniques, researchers hope to refine tremor management strategies and improve patient outcomes.

What evidence suggests that the Encora Pulse device is effective for tremor relief?

Research shows that the Encora Pulse device helps reduce tremors. Studies have found that this wrist-worn device is safe and comfortable for users. It significantly improves tremor control compared to no stimulation. Users noticed better control over their tremors, suggesting the device can ease daily tasks. This trial tests the Encora Pulse device for both Parkinson's Disease and Essential Tremor, aiming to provide relief through its gentle vibrations. ^{1 5 6 7 8}

Who Is on the Research Team?

Ann Marie Murray, MD

Principal Investigator

WVU Comprehensive Movement Disorder Clinic

Are You a Good Fit for This Trial?

This trial is for individuals with Parkinson's Disease or Essential Tremor who are interested in trying a new device called Encora Pulse aimed at relieving tremors. Details about the specific inclusion and exclusion criteria were not provided.

Inclusion Criteria

Beta Phase B2: A wrist circumference of 6.0 - 8.1 inches

I understand the study and can agree to participate.

I have been diagnosed with essential tremor according to TRIG criteria.

Exclusion Criteria

Alpha and Beta Phase B1: History of psoriasis, eczema or atopic dermatitis at the stimulation site

Alpha and Beta Phase B1: Any other medical conditions or physical or mental impairments that in the sponsor/investigator's opinion would render the subject unsuitable as a candidate for the study

Beta Phase B2: Pregnant women

Timeline for a Trial Participant

Alpha Phase

Two remote study visits and an in-home period to gather device usability data on the alpha system. This phase will be used to confirm that the device and labeling are suitable for in-home use.

2 weeks

2 remote visits

Beta Phase B1

Beta Phase B1 will be conducted using the beta devices for two in-person or remote visits to assess design changes between alpha and beta versions.

Not specified

2 visits (in-person or remote)

Beta Phase B2

Seven remote visits and in-home usage to gather usability and efficacy data on the beta system in-home. This phase will be used to assess design changes between alpha and beta versions.

12 weeks

7 remote visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Encora Pulse

Trial Overview The study tests the usability of Encora Pulse, a targeted vibration therapy device, across three phases: an initial two-week home use period (Alpha phase), followed by design assessment visits (Beta Phase B1), and finally a twelve-week in-home usage to evaluate usability and effectiveness (Beta Phase B2).

How Is the Trial Designed?

Group I: D Experimental Treatment 1 Intervention

Order of assessment begins with ADLs and ends with TETRAs, but both are administered backwards

Group II: C Experimental Treatment 1 Intervention

Order of assessment begins with TETRAS and ends with ADLs, but both are administered backwards

Group III: B Experimental Treatment 1 Intervention

Order of assessment begins with ADLs and ends with TETRAs

Group IV: A Experimental Treatment 1 Intervention

Oder of assessment begins with TETRAS and ends with ADLs

Who Is Running the Clinical Trial?

Encora, Inc.

Lead Sponsor

Trials

1

Recruited

100+

Citations

1. neurology.org neurology.org/doi/10.1212/WNL.0000000000211898

Safety and Efficacy of a Wrist-worn Vibratory Stimulation ... The Encora Device was safe and well-tolerated. Both stimulation patterns produced statistically significant improvements compared to Baseline and Sham.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11568799/

Shaking Up Essential Tremor: Peripheral Devices and ... The Tremelo™ device, according to Five Microns, reduces essential tremor by 85–90%, but this claim is not supported by published clinical data, ...

3. businesswire.com businesswire.com/news/home/20241116643792/en/Encora-Therapeutics-Successfully-Completes-ULTRE-Clinical-Trial-Evaluating-Novel-Wrist-Worn-Wearable-for-Essential-Tremor

Encora Therapeutics Successfully Completes ULTRE ... This study evaluated the safety, tolerability, and efficacy of Encora's wrist-worn stimulation device for patients with essential tremor (ET).

4. aan.com aan.com/msa/Public/Events/AbstractDetails/58508

Abstract Details Conclusions The Encora Device was safe and well-tolerated. Both stimulation patterns produced statistically significant improvements compared to Baseline and ...

5. withpower.com withpower.com/trial/phase-parkinson39s-disease-2025-f65e6

Encora Pulse for Tremor Relief This trial is for individuals with Parkinson's Disease or Essential Tremor who are interested in trying a new device called Encora Pulse aimed at relieving ...

6. encoratherapeutics.com encoratherapeutics.com/

Encora Therapeutics You may be eligible to participate in research studies if you experience upper limb tremor. Join patient registry Encora Pulse™ is pending FDA 510(K) review ...

7. prd-journal.com prd-journal.com/article/S1353-8020(25)00197-X/fulltext

Safety and Efficacy of a Wrist-Worn Vibratory Wearable for ... Conclusions: The Encora Device was safe, well-tolerated, and demonstrated significant efficacy in reducing tremor severity. While both stimulations resulted ...

8. neurotherapeuticsjournal.org neurotherapeuticsjournal.org/article/S1878-7479(25)00125-4/fulltext

Safety and efficacy of a wrist-worn vibratory stimulation ... AEs occurred in 5.6% of participants, all mild-to-moderate and resolving without intervention, with 94% rating the device as comfortable. Statistically ...