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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05956223
Recruitment Status : Active, not recruiting
First Posted : July 21, 2023
Last Update Posted : April 11, 2024
Sponsor:
Collaborator:
The Florey Institute of Neuroscience and Mental Health
Information provided by (Responsible Party):
Peter Keller, Royal Victoria Eye and Ear Hospital

Tracking Information
First Submitted Date  ICMJE May 22, 2023
First Posted Date  ICMJE July 21, 2023
Last Update Posted Date April 11, 2024
Actual Study Start Date  ICMJE November 30, 2023
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2023)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Development of a System for Measurement of Tremor
Official Title  ICMJE The Development of a System for Measurement of Tremor
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Essential Tremor
  • Dystonia
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Stage 1 Controls
    Control participants - healthy volunteers without a known neurological disorder
    Intervention: Device: Virtual Reality measurement of essential tremor and dystonia
  • Experimental: Stage 2 Patients with Essential Tremor
    Participants with moderately severe essential tremor
    Intervention: Device: Virtual Reality measurement of essential tremor and dystonia
  • Experimental: Stage 3 Patients with Essential Tremor of varying severities
    Participants with essential tremor ranging from just detectable by neurologist to severe.
    Intervention: Device: Virtual Reality measurement of essential tremor and dystonia
  • Experimental: Stage 5
    Participants with essential tremor and dystonia of the upper limbs, head and neck
    Intervention: Device: Virtual Reality measurement of essential tremor and dystonia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2023)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2025
Estimated Primary Completion Date June 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05956223
Other Study ID Numbers  ICMJE 23-1562H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Peter Keller, Royal Victoria Eye and Ear Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Royal Victoria Eye and Ear Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE The Florey Institute of Neuroscience and Mental Health
Investigators  ICMJE
Principal Investigator: David R Szmulewicz The Royal Victorian Eye and Ear Hospital
PRS Account Royal Victoria Eye and Ear Hospital
Verification Date November 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP