GyroGlove Use in Essential Tremor Patients

This study is testing a wearable device called GyroGlove for people with Essential Tremor (ET), a condition that causes involuntary shaking. The GyroGlove contains small gyroscopes designed to help reduce tremors. Researchers want to see if using the GyroGlove improves tremor symptoms compared to a placebo device (which looks and feels the same but doesn't have the active technology). You might be able to join if you are 18 or older, have been diagnosed with ET, and experience hand tremors that cause issues like spilling water when drinking. The study will measure changes in your tremor symptoms using a special rating scale after two weeks of using the device at home. The current recruitment status is unclear.

Study design: This is a single-blind, placebo-controlled study, meaning you won't know if you're using the active GyroGlove or the placebo at the start. It plans to enroll 30 participants.
What's involved: You will attend two in-clinic visits (Day 0 and Day 14), lasting about 120 minutes and 60-80 minutes respectively. You will also use the GyroGlove at home for two weeks and complete self-assessments at specific times.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint measures changes up to Week 2 (Day 14) after starting the intervention.

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GyroGlove Use in Essential Tremor Patients

Not Yet Recruiting

NAAges 18+InterventionalSupportive care

GyroGear Ltd

~30 participants

Updated 2025-03-14 on ClinicalTrials.gov

What's tested:PlaceboGyroGlove

At a glance

Recruiting sites

0 of 7 listed sites are recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change from Baseline to Week- 2 (follow-up assessment) on The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score performance in ET participants

Measured over Day-0 (Baseline) and Day-14 (follow-up)

Conditions

Essential Tremor

Where it's being run

7 sites across 5 states

England3

Michigan1

Texas1

Vermont1

United Kingdom1

Study leadership

Richard Walker · PRINCIPAL_INVESTIGATOR · North Tyneside General Hospital

Who to contact

Faii Ong

[email protected]

+44 2045773038

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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

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

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

What this trial measures

Change from Baseline to Week- 2 (follow-up assessment) on The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score performance in ET participantsDay-0 (Baseline) and Day-14 (follow-up)
The Essential Tremor Rating Assessment Scale (TETRAS) composite outcome score is the sum of modified items 2, 3, 6 \& 8 of the TETRAS-ADL (Activities of Daily Living) subscale and modified items 6 - 7 of the TETRAS-PS (performance subscale). The TETRAS-ADL subscale is a patient-rated scale administered by a trained interviewer that assesses the impact of tremor on day-to-day functioning, such as feeding with a spoon, drinking from a glass, pouring, using keys etc. The TETARS-PS is a clinical rating scale that quantifies tremor in the head, face, voice, limbs and trunk. Items 6 (drawing an Archimedes spiral) and 7 (handwriting) of the TETRAS-PS evaluate the impact of upper limb tremor on performance. Each item from the modified subscales ranges from 0 - 4, with 0 representing normal and 4 representing severely abnormal. The sum of the 6 items provides the TETRAS composite outcome score, which ranges from 0 - 24, with higher scores representing more severe ET.

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