Clinical trial NCT05956223: The Development of a System for Measurement of Tremor
Official title: The Development of a System for Measurement of Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Essential Tremor
Dystonia
Keywords: Essential Tremor
Dystonia
Virtual Reality
Biokin
Lead sponsor: The Bionics Institute of Australia
Sponsor class: OTHER
First posted: 2023-07-21
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment. Up to 90 participants with Essential Tremor and up to 30 Control participants will be recruited to the study. Both groups will undergo the same intervention.
Primary purpose: OTHER

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 distinguished 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 standardized 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.

Eligibility criteria: Inclusion Criteria - Control participants

* Aged 18 to 80 years
* Able to provide informed consent for self
* Able to comply with all study procedures

Exclusion Criteria -Control participants

* Any neurological disorder
* Any other non-neurological cause of tremor e.g. medication induced

Inclusion Criteria - ET participants

* Aged 18 to 80 years
* Able to provide informed consent for self
* Clinical diagnosis of ET or ET plus syndrome
* Able to comply with all study procedures

Exclusion Criteria - ET Participants

* Tremor other than ET (e.g. parkinsonian, functional tremor)
* Presence of other movement disorder
* For Deep Brain Stimulation (DBS) participants: unwilling or unable to turn off and on their own stimulator for the duration of the study.

Primary outcomes:
measure: 1. To quantify Essential Tremor and dystonia using a measurement system
timeFrame: At enrolment. This study is a single assessment conducted at one time point.
Secondary outcomes:
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: The Royal Victorian Eye and Ear Hospital
state: Victoria
Study officials:
affiliation: The Royal Victorian Eye and Ear Hospital
name: David Szmulewicz, MBBS PhD
role: PRINCIPAL_INVESTIGATOR
References: