Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
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
Download to PDF
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
Query!
Scientific title
The Development of a System for the Measurement of Tremor
Query!
Secondary ID [1]
0
0
23-1562H
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Tremor
0
0
Query!
Condition category
Condition code
Neurological
0
0
0
0
Query!
Other neurological disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
0
0
Treatment: Devices
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
To quantify Essential Tremor and dystonia using a measurement system
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
At enrolment. This study is a single assessment conducted at one time point.
Query!
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
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
80
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
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.
Query!
Study design
Purpose of the study
Other
Query!
Allocation to intervention
N/A
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/08/2023
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
1/12/2024
Query!
Actual
Query!
Sample size
Target
120
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC
Query!
Recruitment hospital [1]
0
0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Query!
Recruitment postcode(s) [1]
0
0
3002 - East Melbourne
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
The Bionics Institute of Australia
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT06386822
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Sarah Osborn, BSc
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
61396677500
Query!
Fax
0
0
Query!
Email
0
0
[email protected]
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT06386822
Download to PDF