GyroGlove Use in Essential Tremor Patients

Part of paid clinical trials in Farmington Hills, Michigan.

Sponsor
GyroGear Ltd
Study ID
NCT05958030
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Essential Tremor

Eligibility Criteria

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

Interventions

  • Placebo — DEVICE
    The placebo device consists of the same hardware as GyroGlove: aesthetically it looks the same, weight same and produces the same noise as GyroGlove. Participants will interact with Placebo on the day of baseline visit (i.e. Day 0).
  • GyroGlove — DEVICE
    GyroGlove is a patented wearable device containing high-performance, miniaturised, gyroscopes designed for individuals diagnosed with essential tremor. Participants will interact with GyroGlove on the day of baseline visit (i.e. Day 0), 2-week Home use and on the day of follow-up visit (i.e Day 14).

Study Details

This is a multi-centre, single-blind, placebo-controlled trial with an open label follow up. After the baseline assessment, all participants will receive the GyroGlove for two weeks during the open label follow up part of the trial. All gloves will be retrieved and returned to GyroGear after closure of the study.

Key Dates

Start date
Jul 31, 2025
Status verified
Mar 2025
Primary completion
Oct 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • No Intervention: No Interventional
    Participants will perform protocol-specific tasks with no device
  • Experimental: Investigational Device Arm
    GyroGlove
  • Placebo Comparator: Placebo Arm
    Placebo

Primary Outcome Measure

Change from Baseline to Week- 2 (follow-up assessment) on The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score performance in ET participants [ Time Frame: Day-0 (Baseline) and Day-14 (follow-up) ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Quest Research InstituteFarmington HillsMichigan48334
Peter LeWitt
[email protected]
248-957-8940
Houston Methodist Stanley H. Appel Department of NeurologyHoustonTexas77030
William Ondo
[email protected]
346-238-9068
University of Vermont Medical CentreBurlingtonVermont05401
James Boyd
[email protected]
802-847-4589

Find similar trials in Farmington Hills, MI

By research site
Quest Research Institute· Farmington Hills, MIHouston Methodist Stanley H. Appel Department of Neurology· Houston, TXUniversity of Vermont Medical Centre· Burlington, VT

Related Studies