Essential Tremor Clinical Trial
Official title:
The Development of a System for Measurement of Tremor
Verified date | May 2024 |
Source | The Bionics Institute of Australia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | June 30, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 Deep Brain Stimulation (DBS) participants: unwilling or unable to turn off and on their own stimulator for the duration of the study. |
Country | Name | City | State |
---|---|---|---|
Australia | The Royal Victorian Eye and Ear Hospital | East Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
The Bionics Institute of Australia |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | At enrolment. This study is a single assessment conducted at one time point. |
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