GyroGlove Use in Essential Tremor Patients
Essential Tremor
About this trial
This is an interventional supportive care trial for Essential Tremor focused on measuring Essential Tremor, Activities of Daily Living
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
Sites / Locations
- Quest Research Institute
- Houston Methodist Stanley H. Appel Department of Neurology
- University of Vermont Medical Centre
- Addenbrooke Hospital, Cambridge University Hospital NHS Trust
- Clinical Ageing Research Unit, Newcastle University
- Oxford University Hospitals NHS Foundation Trust, UK
- North Tyneside General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
No Intervention
Experimental
Placebo Comparator
No Interventional
Investigational Device Arm
Placebo Arm
Participants will perform protocol-specific tasks with no device
GyroGlove
Placebo