History of Changes for Study: NCT05956223

The Development of a System for Measurement of Tremor

A study version is represented by a row in the table.
Select two study versions to compare. One each from columns A and B.
Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
Click "Compare" to do the comparison and show the differences.
Select a version's Submitted Date link to see a rendering of the study for that version.
The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
Hover over the "Recruitment Status" to see how the study's recruitment status changed.
Study edits or deletions are displayed in red.
Study additions are displayed in green.

Study Record Versions

Version	Submitted Date	Changes
1	July 13, 2023	None (earliest Version on record)
2	November 15, 2023	Study Status
3	April 9, 2024	Recruitment Status, Study Status, Contacts/Locations and Oversight
4	May 5, 2024	Sponsor/Collaborators, Arms and Interventions, Study Design, Study Identification, IPDSharing, Study Description, Study Status, Contacts/Locations, Eligibility, Outcome Measures and Conditions

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	23-1562H
Brief Title:	The Development of a System for Measurement of Tremor
Official Title:	The Development of a System for Measurement of Tremor
Secondary IDs:

Study Status


Record Verification:	July 2023
Overall Status:	Not yet recruiting
Study Start:	July 30, 2023
Primary Completion:	June 30, 2025 [Anticipated]
Study Completion:	June 30, 2025 [Anticipated]

First Submitted:	May 22, 2023
First Submitted that Met QC Criteria:	July 13, 2023
First Posted:	July 21, 2023 [Actual]

Last Update Submitted that Met QC Criteria:	July 13, 2023
Last Update Posted:	July 21, 2023 [Actual]

Sponsor/Collaborators


Sponsor:	Royal Victoria Eye and Ear Hospital
Responsible Party:	Principal Investigator Investigator: Peter Keller Official Title: Associate Professor Affiliation: Royal Victoria Eye and Ear Hospital
Collaborators:	The Florey Institute of Neuroscience and Mental Health

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

Study Description

Brief Summary:

This study aims to develop a way of objectively measuring the neurological disorders, Essential Tremor (ET) and Dystonia, and whether it is possible to quantify ET and dystonia using a measurement system in a virtual reality (VR) environment.

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.

We will collect data from measurement sensors embedded in the VR environment from control, ET and dystonic participants by placing them in a VR environment and instructing them to perform the TETRAS. This will help us to develop an algorithm which can measure ET severity using machine learning. We expect that the algorithm will provide a better assessment of ET and dystonia than the TETRAS.

Conditions


Conditions:	Essential Tremor Dystonia
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Diagnostic
Study Phase:	Not Applicable
Interventional Study Model:	Sequential Assignment
Number of Arms:	4
Masking:	None (Open Label)
Allocation:	Non-Randomized
Enrollment:	120 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
Stage 1 Controls Control participants - healthy volunteers without a known neurological disorder	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.
Experimental: Stage 2 Patients with Essential Tremor Participants with moderately severe essential tremor	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.
Experimental: Stage 3 Patients with Essential Tremor of varying severities Participants with essential tremor ranging from just detectable by neurologist to severe.	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.
Experimental: Stage 5 Participants with essential tremor and dystonia of the upper limbs, head and neck	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.

Outcome Measures

Primary Outcome Measures:

TETRAS scores
[ Time Frame: up to 4 weeks ]

The TETRAS has 16 tasks each rated from 1 to 4 with 64 maximum points, with a score of 1 denoting a minimal or barely noticeable tremor and 4 denoting a severe tremor. Scoring for the head provides 8 points; the voice and lower limbs 4 points each; and the upper limb each obtains 20 points, with an extra 4 points for handwriting and 4 for postural tremor.

Eligibility


Minimum Age:	18 Years
Maximum Age:	80 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
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 DBS participants: willingness to turn off their IDU (deep brain stimulator battery) temporarily switched off during their assessment. Participants must have their own ability to turn this back on following the assessment.

Contacts/Locations


Central Contact Person:	Sarah Osborn Telephone: +61428051052 Email: sarah.osborn@unimelb.edu.au
Study Officials:	David R Szmulewicz Principal Investigator The Royal Victorian Eye and Ear Hospital
Locations:	Australia, Victoria
	The Royal Victorina Eye and Ear Hospital East Melbourne, Victoria, Australia, 3002 Contact:Contact: Sarah Osborn +61428051052 sarah.osborn@unimelb.edu.au

IPDSharing


Plan to Share IPD:	Undecided

References


Citations:
Links:
Available IPD/Information: