GyroGlove use in Essential Tremor Patients
Research type
Research Study
Full title
Effectiveness and Safety of GyroGlove in stabilising hand tremors in Essential Tremor
IRAS ID
291446
Contact name
Richard Walker
Contact email
Sponsor organisation
GyroGear Ltd
Duration of Study in the UK
0 years, 3 months, 30 days
Research summary
Essential Tremor (ET) is a very common neurological movement disorders with an estimated 100-200 millions people worldwide. ET sufferers experience tremors, uncontrollable shaking in parts of the body, usually the arms and hands. The presence of tremors, especially when associated to actions, can negatively impact the execution of daily activities of living requiring the use of the hands.
Currently there is no cure for ET and sufferers rely on symptoms management approaches. The available treatments for tremors include pharmacotherapy and brain surgery, including stereotactic thalamotomy or the more common deep brain stimulation (DBS). However, these are compromised by lack of specificity, high associated costs, side effects, poor effectiveness and invasiveness. Pharmacotherapy is often incompletely effective in ET as no disease specific medication exists apart from propranolol. Current technological advancements, however, have brought up new non-invasive solutions that could serve as an adjunct to available treatment options.
This study aims to evaluate the effectiveness and safety of a novel device, the GyroGlove, in stabilising hand tremors in those affected by ET during activities of daily living. The GyroGlove is a wearable device worn over the hand and instrumented with miniaturised gyroscopes that generates a force to counteract hand tremors. Total 80-100 ET patients will be recruited from 6 UK, 4 US and 2 Asia clinical centres. Each participant will be assessed with the GyroGlove, with a placebo glove (no force will be generated) and with no intervention during a baseline assessment after which they will all use the GyroGlove at home for 2 weeks. After 2 weeks another assessment will be performed with the GyroGlove and no device. A combination of clinicians and patients reported outcomes will be used alongside tremor parameters to evaluate the effect of GyroGlove.
REC name
London - Stanmore Research Ethics Committee
REC reference
23/LO/0083
Date of REC Opinion
13 Apr 2023
REC opinion
Further Information Favourable Opinion