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Behavioural Intervention
Investigational Device Arm 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
Study 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 weeks3 visits
Treatment ~ Varies
Follow Up ~ day-1 to day-14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day-1 to day-14
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 moreTrial 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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Who is running the clinical trial?
GyroGear LtdLead Sponsor
Richard WalkerPrincipal InvestigatorNorth Tyneside General Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am 18 years old or older.My medication doses will not change during the study.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.I have received a botulinum toxin injection for hand tremor within the last 4 months.I score 2 or higher in specific daily activities according to the TETRAS scale.I haven't changed my antidepressant medication in the last 3 months.My tremor is not due to Parkinson's, drugs, or natural causes.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational Device Arm
- Group 2: No Interventional
- Group 3: Placebo Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How widely is this trial being administered geographically?
"The research team is recruiting patients from Houston Methodist Stanley H. Appel Department of Neurology in Houston, Texas; University of Vermont Medical Centre in Burlington, Vermont; and Addenbrooke Hospital, Cambridge University Hospital NHS Trust in Cambridge, England as well as 7 further sites."
Answered by AI
Are there any vacancies to participate in this clinical exploration?
"Per information on clinicaltrials.gov, this research study is not presently seeking participants. Although the trial was posted in September of 2023 and last updated in July of that same year, it currently has no vacancies; however, there are 55 other studies searching for volunteers at this time."
Answered by AI
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