Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: 2025 Eurostat Trade Data and Economic Impact
Recruiting Not applicable

Home Use Study of Targeted Mechanical Stimulation for Tremor Relief

NCT07078422 · tracked via the Priya Life Science USA tracker
Sponsor
Encora, Inc
Phase
Not applicable
Started
2025-01-01
Last updated
2025-11-24

Condition(s) studied

Essential TremorParkinson's Disease

Investigational drug(s) / intervention(s)

Encora Pulse

Encora Pulse: The proposed therapeutic device is a wristband that delivers personalized therapeutic relief to users by adjusting parameters of mechanical vibration, tailored to each individual user's tremor. It measures and characterizes users' upper limb tremor before determining what parameters of mechanical vibration should be applied to stimulate the sensory neurons on the wrist. This study will not be conducted under IDE. It is a non-significant risk due to the non-invasive nature of mechanical vibration.

Study summary

Subjects will receive prototype devices to be used for participation. The study comprises three phases:

1. Alpha phase: Two remote study visits and an in-home period to gather device usability data on the alpha system. The at home period for this phase will be 2 weeks. This phase will be used to confirm that the device and labeling are suitable for in-home use.
2. Beta Phase B1: Beta Phase B1 will be conducted using the beta devices for two in-person or remote, 60 to 90-minute, visits. This phase will be used to assess design changes between alpha and beta versions.
3. Beta Phase B2: Seven remote visits and in-home usage to gather usability and efficacy data on the beta system in-home. Beta Phase B2 will be conducted using the beta devices for 12 weeks. This phase will be used to assess design changes between alpha and beta versions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria - Alpha and Beta Phase B1 * Age 18 years or older, able to comply with all study procedures and capable of providing informed consent. * Mentally competent to understand and able to perform written, informed consent to participate in the study * A diagnosis of either ET or PD as determined by clinical history * Moderate to severe upper limb tremor Exclusion Criteria - Alpha and Beta Phase B1 * Pregnant women * Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site * History of psoriasis, eczema or atopic dermatitis at the stimulation site * History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and diabetic neuropathy * Participant unable to communicate with sponsor/investigator and staff * 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. Inclusion Criteria - Beta Phase B2 * Age 18 years or older, able to comply with all study procedures and capable of providing informed consent * Mentally competent to understand and able to perform written, informed consent to participate in the study * For ET subjects, a diagnosis of essential tremor defined as definite or probable ET based on TRIG criteria * For PD subjects, a diagnosis of Parkinson's disease by a Movement Disorder Specialist * For ET subjects, at least one hand exhibiting tremor \> 2 as assessed by the Essential Tremor Rating Assessment Scale (TETRAS) finger to nose task, duck wing task, OR Archimedes Spiral completed during the Screening visit * For PD subjects, a score \> 2 on at least one of MDS-UPDRS items 3.15, 3.16 or 3.17 At the Screening Visit, a score of \> 3 on one of the following subject-assessed items of the Bain \& Findley Activities of Daily Living Scale (BF-ADL): Use a spoon to drink soup, Hold a cup of tea, Do up buttons, Do up a zipper, Write a letter * Stable medications for at least 30 days prior to enrollment and the ability to maintain tremor medications throughout the duration of study participation * For PD subjects, able to participate in visits in a practically defined OFF state (withdrawal from all tremor medication for 12 hours prior to study visits) * A wrist circumference of 6.0 - 8.1 inches Exclusion Criteria - Beta Phase B2 * Pregnant women * Swollen, infected, inflamed areas, or skin eruptions, open wounds, or cancerous lesions of skin at stimulation site * History of psoriasis, eczema or atopic dermatitis at the stimulation site * History of peripheral neuropathy in the upper limbs, including carpal tunnel syndrome and -diabetic neuropathy * Participant unable to communicate with sponsor/investigator and staff * 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

Primary outcome measure(s)

  • Assess the design changes between the alpha and beta versions of the device — Data will be collected at baseline and visit one.
    This outcome measure assesses participants' experiences through an open-ended survey. Participants will be asked to describe their perceptions, symptoms, and overall experiences with the treatment. No predefined responses are given, and answers will be analyzed qualitatively
  • To assess the usability of the beta device in an at-home setting — Data will be collected at baseline, week 1, week 2, month 1, month 2 and month 3.
    Characterization of any unforeseen errors during subject interaction with the packaging device and instructions for use during at-home use will be collected using the usability survey which is an open ended, qualitative survey that measures patient usage error and device related satisfaction

Trial sites (1)

FacilityCityRegionStatus
Encora Therapeutics Cambridge Massachusetts Recruiting

More Encora, Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07078422 on ClinicalTrials.gov ↗ ← All trials in the USA