Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05956223




Registration number
NCT05956223
Ethics application status
Date submitted
22/05/2023
Date registered
21/07/2023
Date last updated
7/05/2024

Titles & IDs
Public title
The Development of a System for Measurement of Tremor
Scientific title
The Development of a System for Measurement of Tremor
Secondary ID [1] 0 0
23-1562H
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Essential Tremor 0 0
Dystonia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Virtual Reality measurement of essential tremor and dystonia

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.


Treatment: Devices: 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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
1. To quantify Essential Tremor and dystonia using a measurement system
Timepoint [1] 0 0
At enrolment. This study is a single assessment conducted at one time point.

Eligibility
Key inclusion criteria
Inclusion Criteria - Control participants

- Aged 18 to 80 years

- Able to provide informed consent for self

- Able to comply with all study procedures
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Other
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
The Bionics Institute of Australia
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05956223
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Szmulewicz, MBBS PhD
Address 0 0
The Royal Victorian Eye and Ear Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05956223