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The Development of a System for Measurement of Tremor

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ClinicalTrials.gov Identifier: NCT05956223
Recruitment Status : Active, not recruiting
First Posted : July 21, 2023
Last Update Posted : May 7, 2024
Sponsor:
Information provided by (Responsible Party):
The Bionics Institute of Australia

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Essential Tremor Dystonia Device: Virtual Reality measurement of essential tremor and dystonia Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single group assignment. Up to 90 participants with Essential Tremor and up to 30 Control participants will be recruited to the study. Both groups will undergo the same intervention.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Development of a System for Measurement of Tremor
Actual Study Start Date : November 30, 2023
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental: Virtual Reality & Movement Monitoring
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.
 Device: Virtual Reality measurement of essential tremor and dystonia

  1. 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.

  2. 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
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 Deep Brain Stimulation (DBS) participants: unwilling or unable to turn off and on their own stimulator for the duration of the study.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05956223


Locations
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Australia, Victoria
The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, Australia, 3002
Sponsors and Collaborators
The Bionics Institute of Australia
Investigators
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Principal Investigator: David Szmulewicz, MBBS PhD The Royal Victorian Eye and Ear Hospital
More Information
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Responsible Party: The Bionics Institute of Australia
ClinicalTrials.gov Identifier: NCT05956223    
Obsolete Identifiers: NCT06386822
Other Study ID Numbers: 23-1562H
First Posted: July 21, 2023    Key Record Dates
Last Update Posted: May 7, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: None. No findings of direct clinical relevance are expected.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Bionics Institute of Australia:
Essential Tremor
Dystonia
Virtual Reality
Biokin
Additional relevant MeSH terms:
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Tremor
Dystonia
Dystonic Disorders
Essential Tremor
Dyskinesias
 Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases