GyroGlove for Essential Tremor

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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How is the GyroGlove treatment different from other treatments for essential tremor?

The GyroGlove is unique because it is a wearable device designed to stabilize hand tremors using gyroscopic technology, unlike other treatments that involve medication or invasive surgical procedures like deep brain stimulation or radiosurgery. ^{1 2 3 4 5}

Research Team

Richard Walker

Principal Investigator

North Tyneside General Hospital

Eligibility Criteria

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

I spill water because of hand tremors when I drink.

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Italy pubmed.ncbi.nlm.nih.gov

DBS, tcMRgFUS, and gamma knife radiosurgery for the treatment of essential tremor: a systematic review on techniques, indications, and current applications. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Pathophysiology and Treatment of Essential Tremor: The Role of Adenosine and Dopamine Receptors in Animal Models. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A case report of complete disappearance of essential tremor after Gamma Knife radiosurgery. [2004]

4. United States pubmed.ncbi.nlm.nih.gov

Stereotactic radiosurgery for essential tremor: Retrospective analysis of a 19-year experience. [2018]

5. France pubmed.ncbi.nlm.nih.gov

[Essential tremor]. [2019]