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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
Awards & highlights

Summary

This trial tests a glove's effect on hand tremors. Participants get the glove for 2 weeks and then its effects are compared to a placebo.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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.

Find a Location

Who is running the clinical trial?

GyroGear LtdLead Sponsor
Richard WalkerPrincipal InvestigatorNorth Tyneside General Hospital

Media Library

GyroGlove (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05958030 — N/A
Essential Tremor Research Study Groups: Investigational Device Arm, No Interventional, Placebo Arm
Essential Tremor Clinical Trial 2023: GyroGlove Highlights & Side Effects. Trial Name: NCT05958030 — N/A
GyroGlove (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05958030 — N/A
~0 spots leftby Aug 2024