GyroGlove Use in Essential Tremor Patients

NCT05958030 | Not Yet Recruiting FDA Device

• 1 other identifier: CLIN-0001
• Study Type: interventional
• Target: 30
• Locations: 2 countries
• Sites: 7

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.

Conditions

Essential Tremor

Keywords

Essential Tremor; Activities of Daily Living

Outcome Measures

Primary Outcomes (1)

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

  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.

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

Secondary Outcomes (12)

• Change in performance in a subset of The Essential Tremor Rating Assessment Scale- performance subscales (TETRAS-PS) between GyroGlove and placebo device at baseline in ET participants

  Day-0 (Baseline)

• Change in Clinical Global Impression- Improvement scale (CGI-I) score between placebo and GyroGlove

  Day-0 (Baseline)

• Change in Patient Global Impression- Improvement scale (PGI-I) score between placebo and GyroGlove

  Day-0 (Baseline)

• Percentage of participants with Investigational devices-related adverse events as assessed by CTCAE v4.0

  Upto Day-14

• Change in performance in a subset of The Essential Tremor Rating Assessment Scale- Activities of Daily Living (TETRAS ADL) subscales between baseline and follow-up assessment in ET participants

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

Study Arms (3)

No Interventional

NO INTERVENTION

Participants will perform protocol-specific tasks with no device

Investigational Device Arm

EXPERIMENTAL

GyroGlove

Device: GyroGlove

Placebo Arm

PLACEBO COMPARATOR

Placebo

Device: Placebo

Interventions

Placebo DEVICE

The placebo device consists of the same hardware as GyroGlove: aesthetically it looks the same, weight same and produces the same noise as GyroGlove. Participants will interact with Placebo on the day of baseline visit (i.e. Day 0).

Placebo Arm

GyroGlove DEVICE

GyroGlove is a patented wearable device containing high-performance, miniaturised, gyroscopes designed for individuals diagnosed with essential tremor. Participants will interact with GyroGlove on the day of baseline visit (i.e. Day 0), 2-week Home use and on the day of follow-up visit (i.e Day 14).

Investigational Device Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GyroGear Ltd: lead

Study Sites (7)

Quest Research Institute

Farmington Hills, Michigan, 48334, United States

Location

Houston Methodist Stanley H. Appel Department of Neurology

Houston, Texas, 77030, United States

Location

University of Vermont Medical Centre

Burlington, Vermont, 05401, United States

Location

Addenbrooke Hospital, Cambridge University Hospital NHS Trust

Cambridge, England, CB2 0QQ, United Kingdom

Location

Clinical Ageing Research Unit, Newcastle University

Newcastle, England, NE4 5PL, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust, UK

Oxford, England, OX3 9DU, United Kingdom

Location

North Tyneside General Hospital

Newcastle, NE29 8NH, United Kingdom

Location

MeSH Terms

Conditions

Essential Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Richard Walker

  North Tyneside General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Faii Ong

CONTACT

+44 2045773038; clinical@gyrogear.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All study participants will interact with both investigational device and placebo in a pre-defined sequence.

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 24, 2023
• Study Start: July 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3); GB (4)