The Development of a System for Measurement of Tremor

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

Tracking Information

• First Submitted Date: May 22, 2023
• First Posted Date: July 21, 2023
• Last Update Posted Date: May 7, 2024
• Actual Study Start Date: November 30, 2023
• Estimated Primary Completion Date: June 30, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 5, 2024)

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.

Original Primary Outcome Measures (submitted: July 13, 2023)

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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Development of a System for Measurement of Tremor
• Official Title: The Development of a System for Measurement of Tremor

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.

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
• Study Phase: Not Applicable

Study Design

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

Condition

• Essential Tremor
• Dystonia

Intervention

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.

Study Arms

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.

Intervention: Device: Virtual Reality measurement of essential tremor and dystonia

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 13, 2023): 120
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2025
• Estimated Primary Completion Date: June 30, 2025 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia

Administrative Information

• NCT Number: NCT05956223
• Other Study ID Numbers: 23-1562H
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: None. No findings of direct clinical relevance are expected.

• Current Responsible Party: The Bionics Institute of Australia
• Original Responsible Party: Peter Keller, Royal Victoria Eye and Ear Hospital, Associate Professor
• Current Study Sponsor: The Bionics Institute of Australia
• Original Study Sponsor: Royal Victoria Eye and Ear Hospital
• Collaborators: Not Provided

Investigators

• Principal Investigator: David Szmulewicz, MBBS PhD; The Royal Victorian Eye and Ear Hospital

• PRS Account: The Bionics Institute of Australia
• Verification Date: May 2024