This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Development of a System for Measurement of Tremor

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05956223
Recruitment Status : Not yet recruiting
First Posted : July 21, 2023
Last Update Posted : July 21, 2023
Sponsor:
Collaborator:
The Florey Institute of Neuroscience and Mental Health
Information provided by (Responsible Party):
Peter Keller, Royal Victoria Eye and Ear Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This study aims to develop a way of objectively measuring the neurological disorders, Essential Tremor (ET) and Dystonia, and whether it is possible to quantify ET and dystonia using a measurement system in a virtual reality (VR) environment.

Condition or disease Intervention/treatment Phase
Essential Tremor Dystonia Device: Virtual Reality measurement of essential tremor and dystonia Not Applicable

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.

We will collect data from measurement sensors embedded in the VR environment from control, ET and dystonic participants by placing them in a VR environment and instructing them to perform the TETRAS. This will help us to develop an algorithm which can measure ET severity using machine learning. We expect that the algorithm will provide a better assessment of ET and dystonia than the TETRAS.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Development of a System for Measurement of Tremor
Estimated Study Start Date : July 30, 2023
Estimated Primary Completion Date : June 30, 2025
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dystonia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Stage 1 Controls
Control participants - healthy volunteers without a known neurological disorder
 Device: Virtual Reality measurement of essential tremor and dystonia

  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: Stage 2 Patients with Essential Tremor
Participants with moderately severe essential tremor
 Device: Virtual Reality measurement of essential tremor and dystonia

  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: Stage 3 Patients with Essential Tremor of varying severities
Participants with essential tremor ranging from just detectable by neurologist to severe.
 Device: Virtual Reality measurement of essential tremor and dystonia

  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: Stage 5
Participants with essential tremor and dystonia of the upper limbs, head and neck
 Device: Virtual Reality measurement of essential tremor and dystonia

  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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. TETRAS scores [ Time Frame: up to 4 weeks ]
    The TETRAS has 16 tasks each rated from 1 to 4 with 64 maximum points, with a score of 1 denoting a minimal or barely noticeable tremor and 4 denoting a severe tremor. Scoring for the head provides 8 points; the voice and lower limbs 4 points each; and the upper limb each obtains 20 points, with an extra 4 points for handwriting and 4 for postural tremor.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 DBS participants: willingness to turn off their IDU (deep brain stimulator battery) temporarily switched off during their assessment. Participants must have their own ability to turn this back on following the assessment.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05956223


Contacts
Layout table for location contacts
Contact: Sarah Osborn +61428051052 sarah.osborn@unimelb.edu.au

Locations
Layout table for location information
Australia, Victoria
The Royal Victorina Eye and Ear Hospital
East Melbourne, Victoria, Australia, 3002
Contact: Sarah Osborn    +61428051052    sarah.osborn@unimelb.edu.au   
Sponsors and Collaborators
Royal Victoria Eye and Ear Hospital
The Florey Institute of Neuroscience and Mental Health
Investigators
Layout table for investigator information
Principal Investigator: David R Szmulewicz The Royal Victorian Eye and Ear Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Peter Keller, Associate Professor, Royal Victoria Eye and Ear Hospital
ClinicalTrials.gov Identifier: NCT05956223    
Other Study ID Numbers: 23-1562H
First Posted: July 21, 2023    Key Record Dates
Last Update Posted: July 21, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dystonia
Tremor
Essential Tremor
Dyskinesias
 Neurologic Manifestations
Nervous System Diseases
Movement Disorders
Central Nervous System Diseases