🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT05958030
Starting soon Not applicable

GyroGlove Use in Essential Tremor Patients

NCT05958030 · tracked via the Priya Life Science USA tracker
Sponsor
GyroGear Ltd
Phase
Not applicable
Started
2025-07
Last updated
2025-03-14

Condition(s) studied

Essential Tremor

Investigational drug(s) / intervention(s)

PlaceboGyroGlove

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).

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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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 language that the trial documentation has been translated to. * Ability to provide written informed consent to participate in the study * Capacity to complete self-report outcome measures in the language that the trial documentation has been translated to Exclusion Criteria: * Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced physiological tremor * Presence of tremor around the elbow and shoulder limiting participants to perform required test/procedure in the study * Has implanted electrical medical device, e.g., pacemaker, defibrillator, or deep brain stimulator * Clinically diagnosed alcohol use disorder or illicit substance use (exception medical cannabis) * Change in medication for tremor within 1 month prior to study enrolment * Change in antidepressant medication within 3 months prior to study enrolment * Has received botulinum toxin injection for hand tremor within 4 months prior to study enrolment * Has been diagnosed with any of the following conditions affecting the hand and/or arm: * Fingers/Wrist joint defects or deformities or current skeletal injuries that prevent them from wearing the glove * Hand muscular deformities or weakness, e.g.: Myotonic Dystrophy, Autosomal Recessive Muscular Dystrophy limiting participant to perform required test/procedure in the study * Skin Conditions of the hand and forearm, e.g.: Eczema, Psoriasis, Extreme Skin Sensitivity * Growth or Development Defects of the hand, including but not limited to, Brittle Bone Disease, Triphalangeal Thumb. * Previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife radio surgical thalamotomy, and focused ultrasound for the treatment of tremor. * Neurological conditions aside from essential tremor that may affect the conduct of the study * Peripheral neuropathy affecting the upper extremity * Are participating or have participated in any interventional clinical trial or study in the last 30 days which may confound the results of this study, unless approved by the Sponsor * Inability to follow simple instructions * Pregnancy

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Quest Research Institute Farmington Hills Michigan
Houston Methodist Stanley H. Appel Department of Neurology Houston Texas
University of Vermont Medical Centre Burlington Vermont
Addenbrooke Hospital, Cambridge University Hospital NHS Trust Cambridge England
Clinical Ageing Research Unit, Newcastle University Newcastle England
Oxford University Hospitals NHS Foundation Trust, UK Oxford England
North Tyneside General Hospital Newcastle United Kingdom

Other trials for the same condition

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 NCT05958030 on ClinicalTrials.gov ↗ ← All trials in the USA