The Development of a System for Measurement of Tremor

NCT05956223 | Completed

• 1 other identifier: 23-1562H
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Tremor; Dystonia

Keywords

Essential Tremor; Dystonia; Virtual Reality; Biokin

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

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.

Device: Virtual Reality measurement of essential tremor and dystonia

Interventions

Virtual Reality measurement of essential tremor and dystonia DEVICE

1. 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.

Experimental: Virtual Reality & Movement Monitoring

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 80 years
• Able to provide informed consent for self
• Able to comply with all study procedures

You may not qualify if:

• Any neurological disorder
• Any other non-neurological cause of tremor e.g. medication induced
• 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 Deep Brain Stimulation (DBS) participants: unwilling or unable to turn off and on their own stimulator for the duration of the study.

Sponsors & Collaborators

• The Bionics Institute of Australia: lead

Study Sites (1)

The Royal Victorian Eye and Ear Hospital

East Melbourne, Victoria, 3002, Australia

Location

MeSH Terms

Conditions

Essential Tremor; Dystonia

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Szmulewicz, MBBS PhD

  The Royal Victorian Eye and Ear Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: July 21, 2023
• Study Start: November 30, 2023
• Primary Completion: November 20, 2024
• Study Completion: November 20, 2024
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)