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NCT05958030 | NOT YET RECRUITING | Essential Tremor

GyroGlove Use in Essential Tremor Patients
Sponsor:

GyroGear Ltd

Brief Summary:

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.

Condition or disease

Essential Tremor

Intervention/treatment

Placebo

GyroGlove

Phase

NA

Detailed Description:

All participants will attend 2 in-clinic assessment sessions (Baseline (day 0), Follow-up (day 14)) after screening visit. The baseline session will last approximately 120 minutes whilst the 2-week assessment will last approximately 60-80 minutes. At baseline assessment, participants will perform protocol-specific activities with both investigational devices (i.e. GyroGlove and Placebo). In addition to in-clinic assessments, participants will complete self-assessments at Day -3 prior baseline visit (i.e. Day 0,) and at Day 5 and 10 from baseline (i.e. Day 0), when they started using GyroGlove at home. All participants will be blinded at the baseline (Day 0), as assessments will be performed with GyroGlove and a placebo device in a pre-defined sequence. Each participant will act as the control for him/herself and will be blinded to the interventions order. The sequence of interventions in the study has been pre-defined, owing to the potential for longitudinal effects of wearing the device interfering with the accurate study outcome measurement.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : DOUBLE
Masking Description : The study is a single-blind study where study participants will be blinded to the order of both devices (investigational device and placebo) during baseline visit.
Primary Purpose : SUPPORTIVE_CARE
Official Title : Effectiveness and Safety of GyroGlove in Stabilising Hand Tremors in Essential Tremor
Actual Study Start Date : 2024-12
Estimated Primary Completion Date : 2025-02
Estimated Study Completion Date : 2025-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
GyroGlove Use in Essential Tremor Patients

Location Details

NCT05958030

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, road cancer

Quest Research Institute

Farmington Hills, road cancer, United States, 48334

Not yet recruiting

United States, Texas

Houston Methodist Stanley H. Appel Department of Neurology

Houston, Texas, United States, 77030

Not yet recruiting

United States, Vermont

University of Vermont Medical Centre

Burlington, Vermont, United States, 05401

Not yet recruiting

United Kingdom, England

Addenbrooke Hospital, Cambridge University Hospital NHS Trust

Cambridge, England, United Kingdom, CB2 0QQ

Not yet recruiting

United Kingdom, England

Clinical Ageing Research Unit, Newcastle University

Newcastle, England, United Kingdom, NE4 5PL

Not yet recruiting

United Kingdom, England

Oxford University Hospitals NHS Foundation Trust, UK

Oxford, England, United Kingdom, Kasa may

Not yet recruiting

United Kingdom,

North Tyneside General Hospital

Newcastle, United Kingdom, NE29 8NH