Effectiveness and Safety of GyroGlove in Stabilising Hand Tremors in Essential Tremor
GyroGear Ltd
Summary
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.
Description
All participants will attend 2 in-clinic assessment sessions (Baseline (day 0), Follow-up (day 14)) after screening visit. The baseline session will last approximately 120 minutes whilst the 2-week assessment will last approximately 60-80 minutes. At baseline assessment, participants will perform protocol-specific activities with both investigational devices (i.e. GyroGlove and Placebo). In addition to in-clinic assessments, participants will complete self-assessments at Day -3 prior baseline visit (i.e. Day 0,) and at Day 5 and 10 from baseline (i.e. Day 0), when they started using GyroGlove…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 18 years of age or older * Subject has been clinically diagnosed with ET * Has either unilateral or bilateral tremor of the hand or predominantly hand as well as forearm * Has a score of ≥ 2 in ADL activities 2, 3, 6 \& 8 of the TETRAS ADL subscale (TRG, Sep 2021) * Tremor in at least one hand causing water spillage during drinking And * Stable dosage of medications throughout the duration of the study, if applicable * Ability to speak and read in the language that the trial documentation has been translated to. * Ability to understand verbal instructions in the langua…
Interventions
- DevicePlacebo
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).
- DeviceGyroGlove
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).
Locations (7)
- Quest Research InstituteFarmington Hills, Michigan
- Houston Methodist Stanley H. Appel Department of NeurologyHouston, Texas
- University of Vermont Medical CentreBurlington, Vermont
- Addenbrooke Hospital, Cambridge University Hospital NHS TrustCambridge, England
- Clinical Ageing Research Unit, Newcastle UniversityNewcastle, England
- Oxford University Hospitals NHS Foundation Trust, UKOxford, England