Did you know?

The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06386822




Registration number
NCT06386822
Ethics application status
Date submitted
22/05/2023
Date registered
21/07/2023
Date last updated
7/05/2024

Titles & IDs
Public title
The Development of a System for Measurement of Tremor
Scientific title
The Development of a System for Measurement of Tremor
Secondary ID [1] 0 0
23-1562H
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Essential Tremor 0 0
Dystonia 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo
Treatment: Devices - Virtual Reality measurement of essential tremor and dystonia

Experimental: Experimental: Virtual Reality & Movement Monitoring - 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.


Treatment: Drugs: Placebo
Etrasimod matching placebo tablet taken by mouth, once daily.

Treatment: Devices: 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.

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
1. To quantify Essential Tremor and dystonia using a measurement system
Timepoint [1] 0 0
At enrolment. This study is a single assessment conducted at one time point.
Primary outcome [2] 0 0
Proportion of Participants with Endoscopic Response [Substudy A]
Timepoint [2] 0 0
Weeks 14 and 52
Primary outcome [3] 0 0
Proportion of Participants With Endoscopic Response [Substudy 1]
Timepoint [3] 0 0
Week 14
Primary outcome [4] 0 0
Proportion of Participants With Endoscopic Response [Substudy 2]
Timepoint [4] 0 0
Week 14
Primary outcome [5] 0 0
Proportion of Participants With Clinical Remission Crohn's Disease Activity Index (CDAI) [Substudy 2]
Timepoint [5] 0 0
Week 14
Primary outcome [6] 0 0
Proportion of Participants With Clinical Remission CDAI [Substudy 3]
Timepoint [6] 0 0
Week 52
Primary outcome [7] 0 0
Proportion of Participants With Endoscopic Response [Substudy 3]
Timepoint [7] 0 0
Week 52
Secondary outcome [1] 0 0
Proportion of Participants With Clinical Remission CDAI [Substudy A]
Timepoint [1] 0 0
Up to Week 66
Secondary outcome [2] 0 0
Change From Baseline in Simple Endoscopic Score in Crohn's Disease (SES-CD) Score [Substudy A]
Timepoint [2] 0 0
Baseline to Week 66
Secondary outcome [3] 0 0
Change From Baseline in CDAI Score [Substudy A]
Timepoint [3] 0 0
Baseline to Week 66
Secondary outcome [4] 0 0
Proportion of Participants With Clinical Remission CDAI [Substudy 1]
Timepoint [4] 0 0
Week 14
Secondary outcome [5] 0 0
Proportion of Participants with Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 1]
Timepoint [5] 0 0
Week 14
Secondary outcome [6] 0 0
Proportion of Participants With Clinical Remission Patient Reported Outcome 2 (PRO2) [Substudy 2]
Timepoint [6] 0 0
Week 14
Secondary outcome [7] 0 0
Proportion of Participants With Clinical Response CDAI [Substudy 2]
Timepoint [7] 0 0
Week 14
Secondary outcome [8] 0 0
Proportion of Participants With Endoscopic Response and Clinical Remission CDAI [Substudy 2]
Timepoint [8] 0 0
Week 14
Secondary outcome [9] 0 0
Proportion of Participants With Endoscopic Remission [Substudy 2]
Timepoint [9] 0 0
Week 14
Secondary outcome [10] 0 0
Change from baseline in CD-PRO/SS [Substudy 2]
Timepoint [10] 0 0
Week 14
Secondary outcome [11] 0 0
Proportion of Participants With Clinical Remission CDAI Among Participants In Clinical Remission CDAI at Substudy 3 Baseline [Substudy 3]
Timepoint [11] 0 0
Week 52
Secondary outcome [12] 0 0
Proportion of Participants With Endoscopic Response Among Participants in Endoscopic Response at Substudy 3 Baseline [Substudy 3]
Timepoint [12] 0 0
Week 52
Secondary outcome [13] 0 0
Proportion of Participants With Corticosteroid-Free Clinical Remission CDAI Among Participants Receiving Corticosteroids at Substudy 3 Baseline [Substudy 3]
Timepoint [13] 0 0
Week 52
Secondary outcome [14] 0 0
Proportion of Participants With Endoscopic Remission [Substudy 3]
Timepoint [14] 0 0
Week 52
Secondary outcome [15] 0 0
Proportion of Participants With Clinical Remission PRO2 [Substudy 3]
Timepoint [15] 0 0
Week 52
Secondary outcome [16] 0 0
Proportion of Participants with Clinical Response or Endoscopic Response [Substudy 3]
Timepoint [16] 0 0
Week 52
Secondary outcome [17] 0 0
Proportion of Participants With Clinical Remission CDAI by Visit up to the End Of Treatment [Substudy 4]
Timepoint [17] 0 0
Up to Week 208
Secondary outcome [18] 0 0
Proportion of Participants With Clinical Remission PRO2 by Visit up to the End Of Treatment [Substudy 4]
Timepoint [18] 0 0
Up to Week 208
Secondary outcome [19] 0 0
Number and Severity of Adverse Events
Timepoint [19] 0 0
Up to approximately 70 weeks for Substudy A,approximately 24 weeks for Substudy 1 and 2; 42 weeks for Substudy 3; and 212 weeks for Substudy 4

Eligibility
Key inclusion criteria
Inclusion Criteria - Control participants

* Aged 18 to 80 years
* Able to provide informed consent for self
* Able to comply with all study procedures
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Other
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,NSW,QLD,WA
Recruitment hospital [1] 0 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment hospital [2] 0 0
Macquarie Respiratory Services - Macquarie University
Recruitment hospital [3] 0 0
Macquarie University Hospital Clinical Trials - Macquarie University
Recruitment hospital [4] 0 0
Macquarie University Hospital Pharmacy - Macquarie University
Recruitment hospital [5] 0 0
Macquarie University Hospital - Macquarie University
Recruitment hospital [6] 0 0
MQ Health Ophthalmology - Macquarie University
Recruitment hospital [7] 0 0
Royal Brisbane & Women's Hospital - Brisbane
Recruitment hospital [8] 0 0
Coral Sea Clinical Research Institute - North Mackay
Recruitment hospital [9] 0 0
MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons - Bellfield
Recruitment hospital [10] 0 0
The Northern Hospital - Epping
Recruitment hospital [11] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [12] 0 0
Footscray Hospital - Melbourne
Recruitment hospital [13] 0 0
Vision Eye Institute - Melbourne
Recruitment hospital [14] 0 0
The Royal Melbourne Hospital - Parkville
Recruitment hospital [15] 0 0
Heidelberg Eye Clinic - Rosanna
Recruitment hospital [16] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [17] 0 0
Lions Eye Institute Limited - Nedlands
Recruitment hospital [18] 0 0
The trustee for The RTS Unit Trust trading as Respiratory Testing Services - O'Connor
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
4740 - North Mackay
Recruitment postcode(s) [5] 0 0
3081 - Bellfield
Recruitment postcode(s) [6] 0 0
3076 - Epping
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
3011 - Melbourne
Recruitment postcode(s) [9] 0 0
3050 - Parkville
Recruitment postcode(s) [10] 0 0
3084 - Rosanna
Recruitment postcode(s) [11] 0 0
6150 - Murdoch
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment postcode(s) [13] 0 0
6163 - O'Connor
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Oklahoma
Country [17] 0 0
United States of America
State/province [17] 0 0
Pennsylvania
Country [18] 0 0
United States of America
State/province [18] 0 0
Texas
Country [19] 0 0
United States of America
State/province [19] 0 0
Virginia
Country [20] 0 0
United States of America
State/province [20] 0 0
Washington
Country [21] 0 0
United States of America
State/province [21] 0 0
West Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Prov. DE Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Santa FE
Country [26] 0 0
Argentina
State/province [26] 0 0
Tucuman
Country [27] 0 0
Argentina
State/province [27] 0 0
Ciudad Autonoma de Bs. As.
Country [28] 0 0
Argentina
State/province [28] 0 0
Ciudad Autonoma de Bs. As
Country [29] 0 0
Austria
State/province [29] 0 0
Graz
Country [30] 0 0
Austria
State/province [30] 0 0
Innsbruck
Country [31] 0 0
Austria
State/province [31] 0 0
Vienna
Country [32] 0 0
Austria
State/province [32] 0 0
Wien
Country [33] 0 0
Belarus
State/province [33] 0 0
Gomel
Country [34] 0 0
Belarus
State/province [34] 0 0
Minsk
Country [35] 0 0
Belarus
State/province [35] 0 0
Mogilev
Country [36] 0 0
Belarus
State/province [36] 0 0
Vitebsk
Country [37] 0 0
Belgium
State/province [37] 0 0
Oost-vlaanderen
Country [38] 0 0
Belgium
State/province [38] 0 0
Vlaams-brabant
Country [39] 0 0
Belgium
State/province [39] 0 0
Gent
Country [40] 0 0
Belgium
State/province [40] 0 0
Leuven
Country [41] 0 0
Belgium
State/province [41] 0 0
Roeselare
Country [42] 0 0
Belgium
State/province [42] 0 0
Torhout
Country [43] 0 0
Belgium
State/province [43] 0 0
Yvoir
Country [44] 0 0
Bosnia and Herzegovina
State/province [44] 0 0
Mostar
Country [45] 0 0
Bosnia and Herzegovina
State/province [45] 0 0
Sarajevo
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Sofia
Country [47] 0 0
Canada
State/province [47] 0 0
Quebec
Country [48] 0 0
Chile
State/province [48] 0 0
Los Rios
Country [49] 0 0
Chile
State/province [49] 0 0
Region Metropolitana
Country [50] 0 0
Chile
State/province [50] 0 0
RM
Country [51] 0 0
Chile
State/province [51] 0 0
Santiago
Country [52] 0 0
Chile
State/province [52] 0 0
Vina del Mar
Country [53] 0 0
Colombia
State/province [53] 0 0
Atlantico
Country [54] 0 0
Colombia
State/province [54] 0 0
Distrito Capital
Country [55] 0 0
Colombia
State/province [55] 0 0
Quindio
Country [56] 0 0
Colombia
State/province [56] 0 0
Valle DEL Cauca
Country [57] 0 0
Croatia
State/province [57] 0 0
Koprivnica
Country [58] 0 0
Croatia
State/province [58] 0 0
Osijek
Country [59] 0 0
Croatia
State/province [59] 0 0
Zadar
Country [60] 0 0
Croatia
State/province [60] 0 0
Zagreb
Country [61] 0 0
Czechia
State/province [61] 0 0
Havirov
Country [62] 0 0
Czechia
State/province [62] 0 0
Horazdovice
Country [63] 0 0
Czechia
State/province [63] 0 0
Hradec Kralove
Country [64] 0 0
Czechia
State/province [64] 0 0
Klatovy
Country [65] 0 0
Czechia
State/province [65] 0 0
Olomouc
Country [66] 0 0
Czechia
State/province [66] 0 0
Ostrava - Hrabuvka
Country [67] 0 0
Czechia
State/province [67] 0 0
Praha 5
Country [68] 0 0
Czechia
State/province [68] 0 0
Praha 9
Country [69] 0 0
Czechia
State/province [69] 0 0
Slany
Country [70] 0 0
Denmark
State/province [70] 0 0
Hovedstaden
Country [71] 0 0
Denmark
State/province [71] 0 0
Aalborg
Country [72] 0 0
Denmark
State/province [72] 0 0
Hvidovre
Country [73] 0 0
Egypt
State/province [73] 0 0
Alexandria
Country [74] 0 0
Egypt
State/province [74] 0 0
Cairo
Country [75] 0 0
Egypt
State/province [75] 0 0
Dakahlia
Country [76] 0 0
Egypt
State/province [76] 0 0
Giza
Country [77] 0 0
Egypt
State/province [77] 0 0
Menofeya
Country [78] 0 0
France
State/province [78] 0 0
Amiens Cedex 1
Country [79] 0 0
France
State/province [79] 0 0
Besancon
Country [80] 0 0
France
State/province [80] 0 0
Clermont-Ferrand
Country [81] 0 0
France
State/province [81] 0 0
Flers
Country [82] 0 0
France
State/province [82] 0 0
Grenoble Cedex 9
Country [83] 0 0
France
State/province [83] 0 0
La Roche sur Yon, Cedex 9
Country [84] 0 0
France
State/province [84] 0 0
Lille, Cedex
Country [85] 0 0
France
State/province [85] 0 0
Montpellier Cedex 5
Country [86] 0 0
France
State/province [86] 0 0
Nice, Cedex 3
Country [87] 0 0
France
State/province [87] 0 0
Reims, Cedex
Country [88] 0 0
France
State/province [88] 0 0
Reims
Country [89] 0 0
France
State/province [89] 0 0
Saint Priest en Jarez
Country [90] 0 0
France
State/province [90] 0 0
Saint-Etienne, Cedex 1
Country [91] 0 0
France
State/province [91] 0 0
Toulouse, Cedex 9
Country [92] 0 0
France
State/province [92] 0 0
Toulouse
Country [93] 0 0
France
State/province [93] 0 0
Vandoeuvre Les Nancy
Country [94] 0 0
Georgia
State/province [94] 0 0
Tbilisi
Country [95] 0 0
Germany
State/province [95] 0 0
Hassen
Country [96] 0 0
Germany
State/province [96] 0 0
Augsburg
Country [97] 0 0
Germany
State/province [97] 0 0
Bonn
Country [98] 0 0
Germany
State/province [98] 0 0
Brandenburg an der Havel
Country [99] 0 0
Germany
State/province [99] 0 0
Dusseldorf
Country [100] 0 0
Germany
State/province [100] 0 0
Frankfurt am Main
Country [101] 0 0
Germany
State/province [101] 0 0
Frankfurt
Country [102] 0 0
Germany
State/province [102] 0 0
Hamburg
Country [103] 0 0
Germany
State/province [103] 0 0
Jena
Country [104] 0 0
Germany
State/province [104] 0 0
Kassel
Country [105] 0 0
Germany
State/province [105] 0 0
Kiel
Country [106] 0 0
Germany
State/province [106] 0 0
Krefeld
Country [107] 0 0
Germany
State/province [107] 0 0
Leipzig
Country [108] 0 0
Germany
State/province [108] 0 0
Neuss
Country [109] 0 0
Germany
State/province [109] 0 0
Nuertingen
Country [110] 0 0
Germany
State/province [110] 0 0
Nurtingen
Country [111] 0 0
Germany
State/province [111] 0 0
Remscheid
Country [112] 0 0
Greece
State/province [112] 0 0
Crete
Country [113] 0 0
Greece
State/province [113] 0 0
Alexandroupoli
Country [114] 0 0
Greece
State/province [114] 0 0
Athens
Country [115] 0 0
Greece
State/province [115] 0 0
Corfu
Country [116] 0 0
Hungary
State/province [116] 0 0
Bekes
Country [117] 0 0
Hungary
State/province [117] 0 0
Csongrad
Country [118] 0 0
Hungary
State/province [118] 0 0
Heves
Country [119] 0 0
Hungary
State/province [119] 0 0
Komarom-esztergom
Country [120] 0 0
Hungary
State/province [120] 0 0
Bekescsaba
Country [121] 0 0
Hungary
State/province [121] 0 0
Budapest
Country [122] 0 0
Hungary
State/province [122] 0 0
Debrecen
Country [123] 0 0
Hungary
State/province [123] 0 0
Pecs
Country [124] 0 0
Hungary
State/province [124] 0 0
Szeged
Country [125] 0 0
Hungary
State/province [125] 0 0
Szekesfehervar
Country [126] 0 0
India
State/province [126] 0 0
Gujarat
Country [127] 0 0
India
State/province [127] 0 0
Haryana
Country [128] 0 0
India
State/province [128] 0 0
Kerala
Country [129] 0 0
India
State/province [129] 0 0
Maharashtra
Country [130] 0 0
India
State/province [130] 0 0
Rajasthan
Country [131] 0 0
India
State/province [131] 0 0
Gurugram, Haryana
Country [132] 0 0
India
State/province [132] 0 0
Kochi
Country [133] 0 0
Ireland
State/province [133] 0 0
Galway
Country [134] 0 0
Israel
State/province [134] 0 0
Afula
Country [135] 0 0
Israel
State/province [135] 0 0
Holon
Country [136] 0 0
Israel
State/province [136] 0 0
Jerusalem
Country [137] 0 0
Israel
State/province [137] 0 0
Nahariya
Country [138] 0 0
Israel
State/province [138] 0 0
Ramat Gan
Country [139] 0 0
Israel
State/province [139] 0 0
Safed
Country [140] 0 0
Israel
State/province [140] 0 0
Tel Aviv
Country [141] 0 0
Italy
State/province [141] 0 0
Bari
Country [142] 0 0
Italy
State/province [142] 0 0
Foggia
Country [143] 0 0
Italy
State/province [143] 0 0
Lombardia
Country [144] 0 0
Italy
State/province [144] 0 0
Milano
Country [145] 0 0
Italy
State/province [145] 0 0
Milan
Country [146] 0 0
Italy
State/province [146] 0 0
MI
Country [147] 0 0
Italy
State/province [147] 0 0
Verona
Country [148] 0 0
Italy
State/province [148] 0 0
Catania
Country [149] 0 0
Italy
State/province [149] 0 0
Catanzaro
Country [150] 0 0
Italy
State/province [150] 0 0
Pavia
Country [151] 0 0
Italy
State/province [151] 0 0
Rome
Country [152] 0 0
Italy
State/province [152] 0 0
Vicenza
Country [153] 0 0
Japan
State/province [153] 0 0
Aichi
Country [154] 0 0
Japan
State/province [154] 0 0
Chiba
Country [155] 0 0
Japan
State/province [155] 0 0
Fukuoka
Country [156] 0 0
Japan
State/province [156] 0 0
Gifu
Country [157] 0 0
Japan
State/province [157] 0 0
Ibaraki
Country [158] 0 0
Japan
State/province [158] 0 0
Kagoshima
Country [159] 0 0
Japan
State/province [159] 0 0
Kumamoto
Country [160] 0 0
Japan
State/province [160] 0 0
Saga
Country [161] 0 0
Japan
State/province [161] 0 0
Tokyo
Country [162] 0 0
Japan
State/province [162] 0 0
Osaka
Country [163] 0 0
Korea, Republic of
State/province [163] 0 0
Gyeonggi-do
Country [164] 0 0
Korea, Republic of
State/province [164] 0 0
Busan
Country [165] 0 0
Korea, Republic of
State/province [165] 0 0
Daegu
Country [166] 0 0
Korea, Republic of
State/province [166] 0 0
Daejeon
Country [167] 0 0
Korea, Republic of
State/province [167] 0 0
Incheon
Country [168] 0 0
Korea, Republic of
State/province [168] 0 0
Seongnam-si
Country [169] 0 0
Korea, Republic of
State/province [169] 0 0
Seoul
Country [170] 0 0
Lebanon
State/province [170] 0 0
Beirut
Country [171] 0 0
Lebanon
State/province [171] 0 0
Saida
Country [172] 0 0
Lebanon
State/province [172] 0 0
Tripoli
Country [173] 0 0
Lithuania
State/province [173] 0 0
Vilnius
Country [174] 0 0
Malaysia
State/province [174] 0 0
Kelantan
Country [175] 0 0
Malaysia
State/province [175] 0 0
Selangor
Country [176] 0 0
Malaysia
State/province [176] 0 0
Kuala Lumpur
Country [177] 0 0
Mexico
State/province [177] 0 0
Guanajuato
Country [178] 0 0
Mexico
State/province [178] 0 0
Jalisco
Country [179] 0 0
Mexico
State/province [179] 0 0
Nuevo LEON
Country [180] 0 0
Mexico
State/province [180] 0 0
Veracruz
Country [181] 0 0
Mexico
State/province [181] 0 0
Chihuahua
Country [182] 0 0
Moldova, Republic of
State/province [182] 0 0
Chisinau
Country [183] 0 0
Netherlands
State/province [183] 0 0
THE Netherlands
Country [184] 0 0
Netherlands
State/province [184] 0 0
Zuid-holland
Country [185] 0 0
Netherlands
State/province [185] 0 0
Amsterdam
Country [186] 0 0
Netherlands
State/province [186] 0 0
Leiden
Country [187] 0 0
Netherlands
State/province [187] 0 0
Nijmegen
Country [188] 0 0
Netherlands
State/province [188] 0 0
Utrecht
Country [189] 0 0
Norway
State/province [189] 0 0
Innlandet
Country [190] 0 0
Norway
State/province [190] 0 0
Oppland
Country [191] 0 0
Norway
State/province [191] 0 0
Lorenskog
Country [192] 0 0
Philippines
State/province [192] 0 0
Metro Manila
Country [193] 0 0
Philippines
State/province [193] 0 0
Metro Mnaila
Country [194] 0 0
Philippines
State/province [194] 0 0
Pampanga
Country [195] 0 0
Poland
State/province [195] 0 0
Wielkopolskie
Country [196] 0 0
Poland
State/province [196] 0 0
Bystra
Country [197] 0 0
Poland
State/province [197] 0 0
Czestochowa
Country [198] 0 0
Poland
State/province [198] 0 0
Dabrowa Gomicza
Country [199] 0 0
Poland
State/province [199] 0 0
Dzierzoniow
Country [200] 0 0
Poland
State/province [200] 0 0
Jelenia Gora
Country [201] 0 0
Poland
State/province [201] 0 0
Karkow
Country [202] 0 0
Poland
State/province [202] 0 0
Katowice
Country [203] 0 0
Poland
State/province [203] 0 0
Krakow
Country [204] 0 0
Poland
State/province [204] 0 0
Ksawerow
Country [205] 0 0
Poland
State/province [205] 0 0
Lodz
Country [206] 0 0
Poland
State/province [206] 0 0
Lublin
Country [207] 0 0
Poland
State/province [207] 0 0
Nowy Targ, Woj. Malopolskie
Country [208] 0 0
Poland
State/province [208] 0 0
Oswiecim
Country [209] 0 0
Poland
State/province [209] 0 0
Piotrkow Trybunalski.
Country [210] 0 0
Poland
State/province [210] 0 0
Piotrkow Trybunalski
Country [211] 0 0
Poland
State/province [211] 0 0
Piotrokow Trybunalski
Country [212] 0 0
Poland
State/province [212] 0 0
Poznan
Country [213] 0 0
Poland
State/province [213] 0 0
Rzeszow
Country [214] 0 0
Poland
State/province [214] 0 0
Sosnowiec
Country [215] 0 0
Poland
State/province [215] 0 0
Strzegom
Country [216] 0 0
Poland
State/province [216] 0 0
Swidnica
Country [217] 0 0
Poland
State/province [217] 0 0
Warszawa
Country [218] 0 0
Poland
State/province [218] 0 0
Wroclaw
Country [219] 0 0
Poland
State/province [219] 0 0
Zamosc
Country [220] 0 0
Poland
State/province [220] 0 0
Zomosc
Country [221] 0 0
Portugal
State/province [221] 0 0
Lisboa
Country [222] 0 0
Puerto Rico
State/province [222] 0 0
Coto Laurel
Country [223] 0 0
Puerto Rico
State/province [223] 0 0
Hato Rey
Country [224] 0 0
Puerto Rico
State/province [224] 0 0
Ponce
Country [225] 0 0
Romania
State/province [225] 0 0
Bihor
Country [226] 0 0
Romania
State/province [226] 0 0
Jud. Cluj
Country [227] 0 0
Romania
State/province [227] 0 0
JUD. Mures
Country [228] 0 0
Romania
State/province [228] 0 0
Jud.constanta
Country [229] 0 0
Romania
State/province [229] 0 0
Sector 3
Country [230] 0 0
Romania
State/province [230] 0 0
Bucuresti
Country [231] 0 0
Russian Federation
State/province [231] 0 0
Stavropol Region
Country [232] 0 0
Russian Federation
State/province [232] 0 0
Kemerovo
Country [233] 0 0
Russian Federation
State/province [233] 0 0
Novosibirsk
Country [234] 0 0
Russian Federation
State/province [234] 0 0
Omsk
Country [235] 0 0
Russian Federation
State/province [235] 0 0
Saint Petersburg
Country [236] 0 0
Russian Federation
State/province [236] 0 0
St. Petersburg
Country [237] 0 0
Russian Federation
State/province [237] 0 0
Stavropol
Country [238] 0 0
Serbia
State/province [238] 0 0
Belgrade
Country [239] 0 0
Serbia
State/province [239] 0 0
Kragujevac
Country [240] 0 0
Serbia
State/province [240] 0 0
Nis
Country [241] 0 0
Serbia
State/province [241] 0 0
Sremska Mitrovica
Country [242] 0 0
Slovakia
State/province [242] 0 0
Banska Bystrica
Country [243] 0 0
Slovakia
State/province [243] 0 0
Bardejov
Country [244] 0 0
Slovakia
State/province [244] 0 0
Kosice
Country [245] 0 0
Slovakia
State/province [245] 0 0
Lipany
Country [246] 0 0
Slovakia
State/province [246] 0 0
Nitra
Country [247] 0 0
Slovakia
State/province [247] 0 0
Presov
Country [248] 0 0
South Africa
State/province [248] 0 0
FREE State
Country [249] 0 0
South Africa
State/province [249] 0 0
Gauteng
Country [250] 0 0
South Africa
State/province [250] 0 0
Western CAPE
Country [251] 0 0
Spain
State/province [251] 0 0
Barcelona
Country [252] 0 0
Spain
State/province [252] 0 0
Ciudad REAL
Country [253] 0 0
Spain
State/province [253] 0 0
Espana
Country [254] 0 0
Spain
State/province [254] 0 0
Alcorcon, Madrid
Country [255] 0 0
Spain
State/province [255] 0 0
Alcorcon
Country [256] 0 0
Spain
State/province [256] 0 0
Las Palmas de Gran Canaria
Country [257] 0 0
Spain
State/province [257] 0 0
Madrid
Country [258] 0 0
Switzerland
State/province [258] 0 0
Baden
Country [259] 0 0
Switzerland
State/province [259] 0 0
Basel
Country [260] 0 0
Switzerland
State/province [260] 0 0
Bern
Country [261] 0 0
Turkey
State/province [261] 0 0
Ankara
Country [262] 0 0
Turkey
State/province [262] 0 0
Antalya
Country [263] 0 0
Turkey
State/province [263] 0 0
Bursa
Country [264] 0 0
Turkey
State/province [264] 0 0
Izmir
Country [265] 0 0
Turkey
State/province [265] 0 0
Kocaeli
Country [266] 0 0
Turkey
State/province [266] 0 0
Yenisehir,Mersin
Country [267] 0 0
Ukraine
State/province [267] 0 0
Chernivtsi
Country [268] 0 0
Ukraine
State/province [268] 0 0
Dnipro
Country [269] 0 0
Ukraine
State/province [269] 0 0
Ivano-Frankivsk
Country [270] 0 0
Ukraine
State/province [270] 0 0
Kharkiv
Country [271] 0 0
Ukraine
State/province [271] 0 0
Kyiv
Country [272] 0 0
Ukraine
State/province [272] 0 0
Lutsk
Country [273] 0 0
Ukraine
State/province [273] 0 0
Lviv
Country [274] 0 0
Ukraine
State/province [274] 0 0
Uzhgorod
Country [275] 0 0
Ukraine
State/province [275] 0 0
Vinnytsia
Country [276] 0 0
United Kingdom
State/province [276] 0 0
Middlesex
Country [277] 0 0
United Kingdom
State/province [277] 0 0
Somerset
Country [278] 0 0
United Kingdom
State/province [278] 0 0
Leeds
Country [279] 0 0
United Kingdom
State/province [279] 0 0
Liverpool, Merseyside
Country [280] 0 0
United Kingdom
State/province [280] 0 0
Liverpool
Country [281] 0 0
United Kingdom
State/province [281] 0 0
London
Country [282] 0 0
United Kingdom
State/province [282] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Other
Name
The Bionics Institute of Australia
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Arena is a wholly owned subsidiary of Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06386822
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Szmulewicz, MBBS PhD
Address 0 0
The Royal Victorian Eye and Ear Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sarah Osborn, BSc
Address 0 0
Country 0 0
Phone 0 0
61396677500
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06386822