Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06386822




Registration number
NCT06386822
Ethics application status
Date submitted
17/04/2024
Date registered
26/04/2024
Date last updated
26/04/2024

Titles & IDs
Public title
The Development of a System for the Measurement of Tremor
Scientific title
The Development of a System for the 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:
Tremor 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - HTC Vive Pro Eye
Treatment: Devices - HTC Vive Tracker
Treatment: Devices - Valve Index Controllers
Treatment: Devices - Biokin

Experimental: Virtual Reality & Movement Monitoring - Participants will don the equipment used to measure their tremor and replicate a series of standardised movements to measure their tremor, in and out of the VR platform.


Treatment: Devices: HTC Vive Pro Eye
A headset worn on the face and head. The headset provides precision eye movement (field of view up to 110 degrees) and face tracking as well as immersing the participant within a visual virtual reality environment with professional-grade graphics and sound. The material is plastic, with a foam facial interface and a hard padded retractable headstrap. The battery is a 700mA fast charging capacity Li-Ion polymer battery). Mode of action is a gyroscope.

Treatment: Devices: HTC Vive Tracker
The HTC Vive Tracker can be placed on the torso or limbs using an antimicrobial fabric strap to precision-detect body movements and position in space. They are plastic and contain 1500mAh Li-Ion polymer batteries. Mode of action is a gyroscope.

Treatment: Devices: Valve Index Controllers
A hand-held device which acts as a controller, with an adjustable strap with antimicrobial fabric. Each controller uses 87 sensors to track hand position, finger position, motion, and pressure to determine user intent. They contain a 900mA fast charging, 1100mAh capacity Li-Ion polymer battery). These controllers determine natural actions like grabbing objects and the sensors will be used to measure tremor in the hands. Mode of action is a gyroscope.

Treatment: Devices: Biokin
The Biokin is composed of a high-computing Micro-Controller Unit (MCU) Cortex, Inertial Measurement Unit (IMU), Wi-Fi module, power management circuit and a rechargeable battery are mounted in the device. The device can be attached to the head or limb. The gyroscopes and accelerometers in the IMU captured inertial changes in acceleration (±8g) and angular velocity (±2000 ?/s) at 100 Hz. Mode of action is the passive recording of kinematics. Application is measuring movement in neurological disease.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
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
- Any neurological disorder

- Any other non-neurological cause of tremor e.g. medication induced

Essential tremor participants:

Inclusion Criteria:

- 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



- Tremor other than ET (e.g. parkinsonian, functional tremor)

- Presence of other movement disorder

- For 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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
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 distingushed 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
standardised 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/NCT06386822
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Osborn, BSc
Address 0 0
Country 0 0
Phone 0 0
61396677500
Fax 0 0
Email 0 0
sosborn@bionicsinstitute.org
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06386822