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The Development of a System for Measurement of Tremor

Primary Purpose

Essential Tremor, Dystonia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Virtual Reality measurement of essential tremor and dystonia
Sponsored by
Royal Victoria Eye and Ear Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Essential Tremor

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Royal Victorina Eye and Ear Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Experimental

Experimental

Experimental

Arm Label

Stage 1 Controls

Stage 2 Patients with Essential Tremor

Stage 3 Patients with Essential Tremor of varying severities

Stage 5

Arm Description

Control participants - healthy volunteers without a known neurological disorder

Participants with moderately severe essential tremor

Participants with essential tremor ranging from just detectable by neurologist to severe.

Participants with essential tremor and dystonia of the upper limbs, head and neck

Outcomes

Primary Outcome Measures

TETRAS scores
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.

Secondary Outcome Measures

Full Information

First Posted
May 22, 2023
Last Updated
July 13, 2023
Sponsor
Royal Victoria Eye and Ear Hospital
Collaborators
The Florey Institute of Neuroscience and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT05956223
Brief Title
The Development of a System for Measurement of Tremor
Official Title
The Development of a System for Measurement of Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 30, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Victoria Eye and Ear Hospital
Collaborators
The Florey Institute of Neuroscience and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Tremor, Dystonia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stage 1 Controls
Arm Type
Other
Arm Description
Control participants - healthy volunteers without a known neurological disorder
Arm Title
Stage 2 Patients with Essential Tremor
Arm Type
Experimental
Arm Description
Participants with moderately severe essential tremor
Arm Title
Stage 3 Patients with Essential Tremor of varying severities
Arm Type
Experimental
Arm Description
Participants with essential tremor ranging from just detectable by neurologist to severe.
Arm Title
Stage 5
Arm Type
Experimental
Arm Description
Participants with essential tremor and dystonia of the upper limbs, head and neck
Intervention Type
Device
Intervention Name(s)
Virtual Reality measurement of essential tremor and dystonia
Intervention Description
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.
Primary Outcome Measure Information:
Title
TETRAS scores
Description
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.
Time Frame
up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Osborn
Phone
+61428051052
Email
sarah.osborn@unimelb.edu.au
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David R Szmulewicz
Organizational Affiliation
The Royal Victorian Eye and Ear Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Royal Victorina Eye and Ear Hospital
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Osborn
Phone
+61428051052
Email
sarah.osborn@unimelb.edu.au

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Development of a System for Measurement of Tremor

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