GyroGlove Use in Essential Tremor Patients

Starting soon · Not applicable · Has a placebo group

Conditions studied: Essential Tremor

In brief

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 facts

Study ID

NCT05958030

Run by

GyroGear Ltd

People needed

30

Starts

2025-07-01

Expected to finish

2025-12-01

Last updated by the study team

2025-03-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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