The Development of a System for the 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 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.

Study Overview

• Status: Recruiting
• Conditions: Tremor
• Intervention / Treatment: Device: HTC Vive Pro Eye; Device: HTC Vive Tracker; Device: Valve Index Controllers; Device: Biokin

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Osborn, BSc; Phone Number: 61396677500; Email: sosborn@bionicsinstitute.org
• Study Contact Backup: Name: Malcolm K Horne, MBBS; Phone Number: 61396677500; Email: mhorne@bionicsinstitute.org

Study Locations

• Australia
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Recruiting
      • The Royal Victorian Eye and Ear Hospital
      • Contact: Sarah Osborn, BSc; Phone Number: 061396677500; Email: sosborn@bionicsinstitute.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Control participants:

Inclusion Criteria:

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

Exclusion Criteria:

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

Essential tremor participants:

Inclusion Criteria:

• 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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Virtual Reality & Movement Monitoring; 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.

Device: HTC Vive Pro Eye; A headset worn on the face and head. The headset provides precision eye movement (field of view up to 110 degrees) and face tracking as well as immersing the participant within a visual virtual reality environment with professional-grade graphics and sound. The material is plastic, with a foam facial interface and a hard padded retractable headstrap. The battery is a 700mA fast charging capacity Li-Ion polymer battery). Mode of action is a gyroscope.; Device: HTC Vive Tracker; The HTC Vive Tracker can be placed on the torso or limbs using an antimicrobial fabric strap to precision-detect body movements and position in space. They are plastic and contain 1500mAh Li-Ion polymer batteries. Mode of action is a gyroscope.; Device: Valve Index Controllers; A hand-held device which acts as a controller, with an adjustable strap with antimicrobial fabric. Each controller uses 87 sensors to track hand position, finger position, motion, and pressure to determine user intent. They contain a 900mA fast charging, 1100mAh capacity Li-Ion polymer battery). These controllers determine natural actions like grabbing objects and the sensors will be used to measure tremor in the hands. Mode of action is a gyroscope.; Device: Biokin; The Biokin is composed of a high-computing Micro-Controller Unit (MCU) Cortex, Inertial Measurement Unit (IMU), Wi-Fi module, power management circuit and a rechargeable battery are mounted in the device. The device can be attached to the head or limb. The gyroscopes and accelerometers in the IMU captured inertial changes in acceleration (±8g) and angular velocity (±2000 ◦/s) at 100 Hz. Mode of action is the passive recording of kinematics. Application is measuring movement in neurological disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: The Bionics Institute of Australia

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Virtual Reality; Essential Tremor; Dystonia; Biokin
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Tremor
• Other Study ID Numbers: 23-1562H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: None. No findings of direct clinical relevance are expected.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No