GyroGlove Use in Essential Tremor Patients
Key facts
- Where
- Burlington, Farmington Hills, and Houston, United StatesSee the 3 sites
Where in United States
- University of Vermont Medical CentreBurlington, United StatesContact: James BoydNo longer taking part
- QUEST Research InstituteFarmington Hills, United StatesContact: Peter LeWittNo longer taking part
- Houston Methodist Stanley H. Appel Department of NeurologyHouston, United StatesContact: William OndoNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- GyroGear Ltd
- Trial code
- NCT05958030
- Record updated
- 14 March 2025
- Original description
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.Read full original descriptionShow less
Effectiveness and Safety of GyroGlove in Stabilising Hand Tremors in Essential Tremor
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.
Inclusion: 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: 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.