Essential TremorNCT05956223
The Development of a System for Measurement of Tremor
A study testing Virtual Reality measurement of essential tremor and dystonia in people with Essential Tremor and Dystonia, run by The Bionics Institute of Australia at 1 site in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Tremor, Dystonia
- What is being tested?
- Virtual Reality measurement of essential tremor and dystonia
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteAustralia
- Study dates
- 30 Nov 2023to 20 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years
- Able to provide informed consent for self
- Able to comply with all study procedures
- 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
Who cannot join
- Any neurological disorder
- Any other non-neurological cause of tremor e.g. medication induced
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Royal Victorian Eye and Ear Hospital
East Melbourne, Victoria, 3002
About this study
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.
Read the 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.
- Conditions
- Essential Tremor, Dystonia
- Being tested
- Virtual Reality measurement of essential tremor and dystonia
- Keywords
- Essential Tremor, Dystonia, Virtual Reality, Biokin
- Medical subject headings
- Essential Tremor, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality measurement of essential tremor and dystoniaDevice
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Virtual Reality & Movement Monitoring | Experimental | 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. Receives: Device: Virtual Reality measurement of essential tremor and dystonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. To quantify Essential Tremor and dystonia using a measurement system
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.
Measured: At enrolment. This study is a single assessment conducted at one time point.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start30 Nov 2023
- Primary completion20 Nov 2024
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Bionics Institute of Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Szmulewicz, MBBS PhD, Principal investigator, The Royal Victorian Eye and Ear Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05956223
- Sponsor's protocol ID
- 23-1562H
- Status last verified
- Apr 2025
- First submitted
- 22 May 2023
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: None. No findings of direct clinical relevance are expected.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a System for Measurement of Tremor
- ClinicalTrials.gov ID
- NCT05956223
- Acronym / sponsor ID
- 23-1562H
- Conditions
- Essential Tremor, Dystonia
- Keywords
- Essential Tremor, Dystonia, Virtual Reality, Biokin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- The Bionics Institute of AustraliaUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Virtual Reality & Movement Monitoring | Experimental | Device: Virtual Reality measurement of essential tremor and dystoniaParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 80 years
- Able to provide informed consent for self
- Able to comply with all study procedures
- Aged 18 to 80 years
- Able to provide informed consent for self
Key exclusion criteria (5 listed)
- Any neurological disorder
- Any other non-neurological cause of tremor e.g. medication induced
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality measurement of essential tremor and dystonia1. 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. | Device | Experimental: Virtual Reality & Movement Monitoring |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: No. None. No findings of direct clinical relevance are expected.
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Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
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Active, not recruitingObservational study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Szmulewicz, MBBS PhD principal investigator
The Royal Victorian Eye and Ear Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality measurement of essential tremor and dystonia in people with Essential Tremor and Dystonia, run by The Bionics Institute of Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.