GyroGlove Use in Essential Tremor Patients

Launched by GYROGEAR LTD · Jul 14, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a special device called the GyroGlove to help people with essential tremor, a condition that causes shaking, particularly in the hands. The goal is to see if this glove can improve daily activities for those affected by this condition. To participate, individuals must be at least 18 years old and have a clinically diagnosed essential tremor that affects their hands. They should also have trouble with tasks like drinking without spilling water due to their tremor.

During the trial, participants will wear the GyroGlove for two weeks, and they will be asked to return it at the end of the study. It’s important that participants have stable medication for their tremor and can understand the instructions provided. However, some people may not be eligible if they have other conditions that cause shaking or certain medical devices implanted in their bodies. The trial is not yet recruiting, but it aims to gather valuable information about how the GyroGlove may help improve the quality of life for those living with essential tremor.

Gender

ALL

Eligibility criteria

• 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