Home Use Study of Targeted Mechanical Stimulation for Tremor Relief

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Encora, Inc.
Study ID
NCT07078422
Status
Recruiting
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Conditions

  • Essential Tremor
  • Parkinson's Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Encora Pulse — DEVICE
    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 Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2025
Completion
Jun 30, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: A
    Oder of assessment begins with TETRAS and ends with ADLs
  • Experimental: B
    Order of assessment begins with ADLs and ends with TETRAs
  • Experimental: C
    Order of assessment begins with TETRAS and ends with ADLs, but both are administered backwards
  • Experimental: D
    Order of assessment begins with ADLs and ends with TETRAs, but both are administered backwards

Primary Outcome Measure

Assess the design changes between the alpha and beta versions of the device [ Time Frame: Data will be collected at baseline and visit one. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Encora TherapeuticsCambridgeMassachusetts02142
Allison Davanzo
[email protected]
855-937-5302

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By research site
Encora Therapeutics· Cambridge, MA

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