The Development of a System for Measurement of Tremor

Essential Tremor Clinical Trial

Official title:

The Development of a System for Measurement of Tremor

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05956223
• Other study ID #: 23-1562H
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 30, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: The Bionics Institute of Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT06386822

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Essential Tremor
• Tremor

Intervention

Device:
• Virtual Reality measurement of essential tremor and dystonia
The virtual reality (VR) platform, which detects whole-of-body movements. The VR environment is a series of sensors in a room that detect whole body motion and a series of sensors worn by the participant. As well the participant dons VR "goggles" that allows them to "see" a virtual environment in which they can perform the TETRAS. Within the VR platform, an avatar (an electronic image that represents the participant) is produced in the VR environment, and this will be used to review the participant. Sensors for the detection of wrist, head and voice tremor. The sensors are small devices worn on the wrists and head of the participant and are similar to those used in the VR system. A microphone is attached to the participants to detect voice tremor.

Locations

Country	Name	City	State
Australia	The Royal Victorian Eye and Ear Hospital	East Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
The Bionics Institute of Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. To quantify Essential Tremor and dystonia using a measurement system	Using commercially available Virtual Reality (VR) equipment and a commercially available Inertial Measurement Unit (IMU), the presence of the tremor and dystonia in participants with Essential Tremor will be measured and their severity rated.	At enrolment. This study is a single assessment conducted at one time point.