Completed

NCT Number: NCT05956223

The Development of a System for Measurement of Tremor

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.

Completed

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Key information

Conditions

Essential Tremor Central Nervous System Diseases Dyskinesias Dystonia Movement Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, 3002, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Virtual Reality measurement of essential tremor and dystonia

Device

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.

Primary outcomes

1. To quantify Essential Tremor and dystonia using a measurement system

Time frame: At enrolment. This study is a single assessment conducted at one time point.

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.

Sponsors and collaborators

Lead sponsor

The Bionics Institute of Australia

Other

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jul 21, 2023
Registry last updated: Apr 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed