What side effects are associated with this type of intervention?

Common treatments for Essential Tremor include pharmacological options like propranolol and primidone, which can cause side effects such as fatigue, dizziness, and nausea. Non-pharmacological treatments, such as the GyroGlove, aim to stabilize hand tremors mechanically and generally have fewer systemic side effects. However, device-specific issues like discomfort or skin irritation may occur. Other non-pharmacological treatments like deep brain stimulation (DBS) can lead to complications such as infection, bleeding, or hardware-related issues.

What prior FDA approvals exist?

The FDA has approved several pharmacologic treatments for Essential Tremor, including propranolol and primidone, which are commonly used to manage symptoms. Additionally, deep brain stimulation (DBS) is an FDA-approved surgical treatment that can significantly reduce tremors. While the GyroGlove, which uses gyroscopic stabilization to manage hand tremors, represents a novel approach, there are no specific FDA-approved devices that use a similar mechanical stabilization method for Essential Tremor as of now.

What other types of research exist?

Promising novel alternatives to GyroGlove for Essential Tremor patients include: 1) High-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex, which has shown efficacy in alleviating upper limb dystonia. 2) Transcutaneous supraorbital nerve stimulation, which has demonstrated benefits in reducing migraine days and could potentially be adapted for tremor management. 3) Vagus nerve stimulation (VNS), which has shown positive outcomes in treatment-resistant depression and may offer benefits for tremor control. These alternatives are supported by clinical trials and systematic reviews indicating their potential effectiveness.

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Behavioural Intervention

GyroGlove for Essential Tremor

N/A

Waitlist Available

Led By Richard Walker

Research Sponsored by GyroGear Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day-1 to day-14

Summary

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 other treatments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves wearing a glove rather than taking medication, typical drug side effects are not expected. However, discomfort or skin irritation from the glove could occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day-1 to day-14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day-1 to day-14

This trial's timeline: 3 weeks for screening, Varies for treatment, and day-1 to day-14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in Clinical Global Impression- Improvement scale (CGI-I) score between baseline and follow-up assessment in ET participants

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

Change in EQ-5D-5L score between baseline and follow-up assessment in ET participants

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Investigational Device ArmExperimental Treatment1 Intervention

GyroGlove

Group II: No InterventionalActive Control1 Intervention

Participants will perform protocol-specific tasks with no device

Group III: Placebo ArmPlacebo Group1 Intervention

Placebo

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Essential Tremor (ET) include pharmacologic agents like propranolol, which works by blocking beta-adrenergic receptors to reduce tremor amplitude, and botulinum toxin injections, which temporarily paralyze overactive muscles. Adaptive devices, such as neuromodulation and biomechanical loading, offer noninvasive options to manage tremor severity. Neuromodulation involves electrical stimulation of nerves to modulate tremor signals, while biomechanical loading uses external forces or robotic exoskeletons to stabilize tremulous limbs. These treatments are crucial for ET patients as they provide various methods to control tremor, improving daily function and quality of life. The GyroGlove, which uses gyroscopic stabilization, aligns with these adaptive strategies by providing real-time tremor reduction, enhancing hand stability and patient independence.

Focal dystonia and repetitive motion disorders.