Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-05-06 @ 8:27 PM
Study NCT ID:
NCT06386822
Status:
Recruiting
Last Update Posted:
April 26 2024
First Post:
April 17 2024
Brief Title:
The Development of a System for the Measurement of Tremor
Sponsor:
The Bionics Institute of Australia
Organization:
The Bionics Institute of Australia
Study Overview
Official Title:
The Development of a System for the Measurement of Tremor
Status:
Recruiting
Status Verified Date:
April 2024
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to develop a system which can be used to measure movements in people with Essential Tremor with or without dystonia The main questions it aims to answer are
Can individuals with Essential Tremor be distingushed from individuals without tremor using Virtual Reality VR
Can the current Essential Tremor Assessment Scale the TETRAS be reproduced in VR
Can Essential Tremor be quantified using a measurement system
Can Dystonia be quantified using a measurement system
Participants will don the equipment used to measure their tremor and replicate a series of standardised movements to measure their tremor in and out of the VR platform The assessment will take no longer than an hour
Can individuals with Essential Tremor be distingushed from individuals without tremor using Virtual Reality VR
Can the current Essential Tremor Assessment Scale the TETRAS be reproduced in VR
Can Essential Tremor be quantified using a measurement system
Can Dystonia be quantified using a measurement system
Participants will don the equipment used to measure their tremor and replicate a series of standardised movements to measure their tremor in and out of the VR platform The assessment will take no longer than an hour
Detailed Description:
This study aims to develop a way of objectively measuring the neurological disorders Essential Tremor ET and dystonia These conditions can affect the upper and lower limbs head voice face and trunk ET and dystonia can be difficult to assess and treat particularly if severe and therapies are limited Currently the severity of these conditions is formally assessed by clinician rated scales such as the Essential Tremor Rating Assessment Scale TETRAS which is biased towards the upper limbs requires training and is not objective There is a need for a more precise less variable measure of tremor that can used easily be non-expert clinicians This study questions whether it is possible to quantify ET and dystonia using a measurement system in a virtual reality VR environment
Data will be collected from measurement sensors embedded in the VR environment from healthy control participants and those with ET with and without dystonia Participants will be placed in a VR environment and instructed to perform the TETRAS This will help to develop an algorithm which can measure ET severity using machine learning It is expected that the algorithm will provide a better assessment of ET and dystonia than the TETRAS This study may pave the way towards the development of simpler devices to which the algorithm can be applied
Data will be collected from measurement sensors embedded in the VR environment from healthy control participants and those with ET with and without dystonia Participants will be placed in a VR environment and instructed to perform the TETRAS This will help to develop an algorithm which can measure ET severity using machine learning It is expected that the algorithm will provide a better assessment of ET and dystonia than the TETRAS This study may pave the way towards the development of simpler devices to which the algorithm can be applied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None