GyroGlove for Essential Tremor

Not yet recruiting at 6 trial locations

Overseen By Faii Ong

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GyroGear Ltd

Must not be taking: Antidepressants, Botulinum toxin

Disqualifiers: Parkinson's, Alcohol use disorder, Pregnancy, others

Compensation: Varies

Number of Visits: 6

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the effectiveness of the GyroGlove, a wearable device designed to help people with essential tremor, a condition that causes involuntary shaking, usually in the hands. The study will compare the GyroGlove's performance with a placebo and no-device scenarios to evaluate its ability to reduce tremors. Participants should have essential tremor affecting their hands, causing issues such as spilling water when drinking. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance the quality of life for those with essential tremor.

Do I need to stop my current medications for the trial?

The trial requires that you keep a stable dosage of your current medications throughout the study, if applicable. This means you should not change your medication dosage during the trial.

What prior data suggests that the GyroGlove is safe for essential tremor?

Research shows that the GyroGlove helps reduce tremors in people with conditions like Essential Tremor and Parkinson's Disease. One study found that the GyroGlove reduced tremors by 52% in six patients, suggesting its effectiveness in managing tremor symptoms.

However, limited published information exists on the GyroGlove's safety. As a non-invasive device, it is generally expected to be safe and well-tolerated. Users have reported benefits such as less severe tremors and improved quality of life.

Since this is a new device, considering potential risks or discomforts is important, even if not well-documented yet. Participation in a trial like this can help gather more safety information for future users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The GyroGlove is unique because it uses a gyroscopic mechanism to help stabilize the hands of people with essential tremor. Unlike traditional treatments like medications (such as beta-blockers and anticonvulsants) or invasive procedures (like deep brain stimulation), the GyroGlove offers a non-invasive and immediate way to reduce tremors. Researchers are excited about this wearable device because it provides real-time assistance, potentially improving the quality of life for users without the side effects associated with drugs or the risks of surgery.

What evidence suggests that the GyroGlove is effective for essential tremor?

Research has shown that the GyroGlove reduces hand tremors in people with essential tremor. Studies have found that using the GyroGlove lessens tremor severity, easing daily tasks. Some participants reported better control of hand movements and improved quality of life. In this trial, participants in the Investigational Device Arm will use the GyroGlove, which employs gyroscopes—spinning devices that steady the hand. This technology stabilizes the hand, allowing for smoother movements. Early results suggest that the GyroGlove could be a promising option for those dealing with hand tremors. ^{3 5 6 7 8}

Who Is on the Research Team?

Richard Walker

Principal Investigator

North Tyneside General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Essential Tremor (ET) who can follow instructions and have a stable medication dosage. They must experience hand tremors that cause spills when drinking, but not be pregnant, use certain substances, or have conditions like Parkinson's disease or implanted electrical devices.

Inclusion Criteria

I have been diagnosed with essential thrombocythemia (ET).

I spill water because of hand tremors when I drink.

I experience shaking in one or both of my hands or mostly in my hands and forearms.

Exclusion Criteria

Clinically diagnosed alcohol use disorder or illicit substance use (exception medical cannabis)

I haven't changed my tremor medication in the last month.

I have tremors in my arm that make it hard to do certain tasks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline Assessment

Participants perform protocol-specific activities with both investigational devices (GyroGlove and Placebo) in a blinded sequence

1 day

1 visit (in-person)

Treatment

Participants use the GyroGlove at home and complete self-assessments

2 weeks

Self-assessments on Day -3, Day 5, and Day 10

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 day

1 visit (in-person)

Open-label Extension

Participants receive the GyroGlove for two weeks during the open label follow up part of the trial

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• GyroGlove

Trial Overview

The GyroGlove is being tested against a placebo in people with ET. Participants will first try the glove for two weeks to see if it helps control their tremors. The study design includes an initial assessment followed by this open label period where everyone gets the real glove.

How Is the Trial Designed?

Group I: Investigational Device Arm Experimental Treatment 1 Intervention

GyroGlove

Group II: No Interventional Active Control 1 Intervention

Participants will perform protocol-specific tasks with no device

Group III: Placebo Arm Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

GyroGear Ltd

Lead Sponsor

Trials

1

Recruited

30+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11568799/

Shaking Up Essential Tremor: Peripheral Devices and ...

The Tremelo™ device, according to Five Microns, reduces essential tremor by 85–90%, but this claim is not supported by published clinical data, ...

2.

researchgate.net

researchgate.net/publication/377562528_Effectiveness_of_Gyro_Based_Handglove_for_Improving_Activities_of_Daily_Living_among_the_Individuals_Suffering_with_Hand_Tremors

(PDF) Effectiveness of Gyro Based Handglove for ...

The purpose of this study is to reducehand tremors with the help of gyro based hand glove to improve the activities of daily living of the patient.

3.

neurologycongress.com

neurologycongress.com/program/scientific-program/2023/efficacy-of-the-gyroglove-in-modulating-hand-tremors-in-essential-tremor-a-self-controlled-pilot-study

Efficacy of the gyroglove in modulating hand tremors ...

In this study, we investigated the efficacy of the GyroGlove in modulating hand tremors in participants with ET.

4.

bibliomed.org

bibliomed.org/fulltextpdf.php?mno=159267

Gyro Glove: Stabilizing The Lives Of Those With Hand ...

The positive outcomes, including reduced tremor severity, enhanced functional abilities, and improved quality of life, underscore the importance of gyroscopic ...

5.

withpower.com

withpower.com/trial/phase-tremor-8-2023-2d7ad

GyroGlove for Essential Tremor · Info for Participants

This trial tests the GyroGlove, a special glove that helps reduce hand tremors using gyroscopes. It targets people with hand tremors who may not respond well to ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8065649/

Medical Devices for Tremor Suppression: Current Status and ...

This device was found to have a 52% tremor suppression in six patients with ET or PD tremors (p < 0.001) [81]. Conversely, the Tremor's glove stimulates the ...

7.

tremorjournal.org

tremorjournal.org/articles/10.5334/tohm.930

Peripheral Devices and Mechanical Strategies to Reduce ...

This review discusses non-pharmacological, non-surgical interventions for action tremor, including essential tremor (ET).

8.

gyrogear.co

gyrogear.co/product/gyroglove/

GyroGlove

GyroGlove™ is a new product designed to provide temporary relief to individuals suffering from chronic hand tremors, such as Parkinson's Disease or Essential ...