GyroGlove, a wearable device, for hand tremor in essential tremor

Who can take part

• 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

Who cannot take part

• 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
• Previous thalamotomy procedure, including stereotactic thalamotomy, gamma knife radio surgical thalamotomy, and focused ultrasound for the treatment of tremor
• Other possible causes of tremor, including Parkinson's disease, drug-induced, enhanced physiological tremor
• Clinically diagnosed alcohol use disorder or illicit substance use (exception medical cannabis)
• 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
• Neurological conditions aside from essential tremor that may affect the conduct of the study
• 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
• 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