UMIN-ICDS Clinical Trial

Public title

Creating a visual stimulator

Acronym

Creating a visual stimulator

Scientific Title

Creating a visual stimulator using a head-mounted display (HMD)

Scientific Title:Acronym

Creating a visual stimulator using HMD

Region

Japan

Condition

Vestibular disorder

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Seasickness and virtual reality sickness are known to cause equilibrium dysfunction due to a "mismatch" between somatosensory (mainly through skin and muscle sensation) and visual sensations, but it is known to become accustomed (adaptation). Responses adapted by somatosensory or visual sensations are referred to as adaptive phenomena, which we examined using rotation testing and a flat and spherical screen with projected black and white stripes, as well as visual vestibular inconsistency stimulation. The results of our previous studies showed that a flat screen under off-vertical axis rotation (OVAR) and a spherical screen under earth vertical axis rotation (EVAR) were suitable for visual vestibular inconsistency stimulation. Visual stimulation of linear motion was suitable for otolith-ocular reflex (OOR) and visual stimulation of rotational angular rate motion for semicircular canal-ocular reflex (ScOR).
The purpose of this study is to reaffirm previous research by using computer graphic techniques to perform pseudo-linear and pseudo-rotational visual stimuli. The eventual goal is to obtain the basic data necessary to appropriately select the modality of visual stimulation to be used during rehabilitation, depending on the site of the disorder, in cases where the semicircular canal is impaired or the otolith is impaired.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Using the created HMD, perform pseudo-linear and pseudo-rotational visual stimulation on the subject. Subjects will be asked to complete a questionnaire immediately following the study. Evaluate the validity of the stimuli by asking the participants to describe whether they feel as if they moved reality in a straight line when they experienced the pseudo-linear visual stimuli, and whether they feel as if they rotated reality when they experienced the pseudo-rotational visual stimuli ("felt", "felt a little", or "did not feel").

Key secondary outcomes

Using the created HMD, perform pseudo-linear and pseudo-rotational visual stimulation on the subject. Subjects will be asked to complete a questionnaire immediately following the study. The participants will be asked to describe whether nausea or other symptoms appeared during the test ("felt", "felt a little", or "did not feel") to evaluate safety.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The participants will wear a head-mounted display (HMD).
Pseudo-linear and pseudo-rotational visual stimuli are added on the HMD, and the visibility is verified by a questionnaire method. The test time is approximately 30 minutes. The test will be conducted only once per subject.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Healthy subjects who do not have an equilibrium disorder and who have given their free and voluntary written consent to participate in this study, after having demonstrated sufficient understanding of the study after the explanation of the study.

Key exclusion criteria

Cases in which consent was not obtained, and other cases in which participation in the study was deemed impossible due to medical conditions or physical condition.

Target sample size

30

Name of lead principal investigator

1st name	Izumi
Middle name
Last name	Koizuka

Organization

St. Marianna University School of Medicine

Division name

Otorhinolaryngology

Zip code

216-8511

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan

TEL

044-977-8111(ext.3261)

Email

koizuka@marianna-u.ac.jp

Name of contact person

1st name	Yusuke
Middle name
Last name	Ito

Organization

St. Marianna University School of Medicine

Division name

Otorhinolaryngology

Zip code

216-8511

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan

TEL

044-977-8111(ext.3261)

Homepage URL

Email

yusuke.ito@marianna-u.ac.jp

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name

Organization

Ministry of Education, Culture, Sports, Science and
Technology

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Nagashima Medical Instruments.Co.,Ltd.

Name of secondary funder(s)

Organization

St. Marianna University School of Medicine

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511 Japan

Tel

044-977-8111

Email

k-sienbu.mail@marianna-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

10

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2022

Year

07

Month

12

Day

Date of IRB

Anticipated trial start date

2022

Year

10

Month

18

Day

Last follow-up date

2023

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

10

Month

18

Day

Last modified on

2022

Year

10

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056017