The Development of a System for Measurement of Tremor

Sponsor
Royal Victoria Eye and Ear Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05956223
Collaborator
The Florey Institute of Neuroscience and Mental Health (Other)
120
1
4
23
5.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality measurement of essential tremor and dystonia
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
The Development of a System for Measurement of Tremor
Anticipated Study Start Date :
Jul 30, 2023
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Jun 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: 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

  1. TETRAS scores [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 Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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 and Locations

Locations

Site City State Country Postal Code
1 The Royal Victorina Eye and Ear Hospital East Melbourne Victoria Australia 3002

Sponsors and Collaborators

  • Royal Victoria Eye and Ear Hospital
  • The Florey Institute of Neuroscience and Mental Health

Investigators

  • Principal Investigator: David R Szmulewicz, The Royal Victorian Eye and Ear Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peter Keller, Associate Professor, Royal Victoria Eye and Ear Hospital
ClinicalTrials.gov Identifier:
NCT05956223
Other Study ID Numbers:
  • 23-1562H
First Posted:
Jul 21, 2023
Last Update Posted:
Jul 21, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2023