GyroGlove for Essential Tremor
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.12345Why 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.35678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants perform protocol-specific activities with both investigational devices (GyroGlove and Placebo) in a blinded sequence
Treatment
Participants use the GyroGlove at home and complete self-assessments
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label Extension
Participants receive the GyroGlove for two weeks during the open label follow up part of the trial
What Are the Treatments Tested in This Trial?
Interventions
- GyroGlove
Find a Clinic Near You
Who Is Running the Clinical Trial?
GyroGear Ltd
Lead Sponsor