Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-07-31
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Upper Limb Tremor Reduction in Essential Tremor Patients
NCT06343285
Study to Evaluate SAGE-324 in Participants With Essential Tremor
NCT05173012
A Study to Evaluate the Long-term Safety and Tolerability of SAGE-324 in Participants With Essential Tremor
NCT05366751
Safety, Efficacy, and Tolerability of NBI-827104 for the Treatment of Essential Tremor
NCT04880616
A Study to Evaluate the Efficacy, Safety, and Tolerability of SAGE-324 in Participants With Essential Tremor
NCT04305275
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
No Interventional
Participants will perform protocol-specific tasks with no device
No interventions assigned to this group
Investigational Device Arm
GyroGlove
GyroGlove
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).
Placebo Arm
Placebo
Placebo
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
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).
GyroGlove
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GyroGear Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Richard Walker
Role: PRINCIPAL_INVESTIGATOR
North Tyneside General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Quest Research Institute
Farmington Hills, Michigan, United States
Houston Methodist Stanley H. Appel Department of Neurology
Houston, Texas, United States
University of Vermont Medical Centre
Burlington, Vermont, United States
Addenbrooke Hospital, Cambridge University Hospital NHS Trust
Cambridge, England, United Kingdom
Clinical Ageing Research Unit, Newcastle University
Newcastle, England, United Kingdom
Oxford University Hospitals NHS Foundation Trust, UK
Oxford, England, United Kingdom
North Tyneside General Hospital
Newcastle, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLIN-0001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.