NCT05958030

GyroGlove Use in Essential Tremor Patients

Effectiveness and Safety of GyroGlove in Stabilising Hand Tremors in Essential Tremor

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: GyroGear Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 at home. All participants will be blinded at the baseline (Day 0), as assessments will be performed with GyroGlove and a placebo device in a pre-defined sequence. Each participant will act as the control for him/herself and will be blinded to the interventions order. The sequence of interventions in the study has been pre-defined, owing to the potential for longitudinal effects of wearing the device interfering with the accurate study outcome measurement.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
DEVICE	Placebo	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).
DEVICE	GyroGlove	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).

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2023-07-24
• Last updated: 2025-03-14

Locations

7 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated device study