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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028848
Receipt No. R000033015
Scientific Title The analysis on quantification of eye movement tracking in cerebral concussion
Date of disclosure of the study information 2017/08/28
Last modified on 2019/08/29

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Basic information
Public title The analysis on quantification of eye movement tracking in cerebral concussion
Acronym ETCC
Scientific Title The analysis on quantification of eye movement tracking in cerebral concussion
Scientific Title:Acronym ETCC
Region
Japan

Condition
Condition cerebral concussion
Classification by specialty
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We measure the eye movement tracking of healthy and cerebral concussion patients, and clarify the method of quantitatively assessing and diagnosing the degree of disability. In this research we will obtain knowledge of disability by cerebral concussion, and of the safety return to competition.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Eye movement tracking during recovery process after cerebral concussion


1. Athlete
Registration1-1; Register and measure before the season begins
Registration1-2; Registration and measurement during season
Register1-3I; Register and measure after the end of the season

2. Patient
Registration 2-1; Within 3 days of injury, registration and measurement
Registration 2-2; 1-2 weeks after injury symptom hearing and measurement
Registration 2-3; symptom hearing and measurement 1 to 2 months after injury
Key secondary outcomes 1. Eye movement tracking individual differences at non-cerebral concussion
2. Changes in eye movement tracking accompanying cerebral concussion symptomatic transition
3. Verification of validity of stepwise competition return after cerebral concussion
4. Verification of association between cerebral concussion symptoms and eye movement tracking
5. Other adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 LTOG (Limbus Tracking Oculography)
LTOG optically measures the positions of the black eyes by measuring the amount of reflected light by irradiating infrared rays on the white eye and the black eye, and saves the result as a digital data format. LTOG shows a rotation index that makes a constant rotation to make the eyeball perform a parachute (follow-up movement), a method to make the eyeball alternately turn on the LEDs at a distance to make a saccade (leaping movement), stop one point Let the fixation microtremor, which is the fluctuation of the eyeball occurred in the case of the eye movement.
The LTOG device is installed in the darkroom of the sports medicine practice room at St. Marianna University School Gymnasium and in the heart sound room (darkroom) on the 2nd floor of St. Maryanna Medical University Hospital. Measure eye movement by wearing goggles and tracking movement of light by LED lighting. The time required for measurement alone is about 20 seconds per person. It is estimated that it takes about 10 minutes to wear goggles and set up personal computers before and after.
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

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Over 18 years old
2. St. Marianna University School of Medicine Competitors (hereinafter referred to as competitors) who belong to athletic meetings conducting contact sports such as the American Football Club, Rugby Club and Soccer Club,
3. St. Marianna University School of Medicine Hospital Patients who received diagnosis of brain shaking by sports at the Department of Neurosurgery Outpatient (hereinafter referred to as patients)
4. After receiving sufficient explanation for the participation of this study, after sufficient understanding, the competitor and patient who got document consent by the patient's free will
Key exclusion criteria 1. Can not keep peace
2. History of eye diseases and epilepsy accompanied by decreased vision
3. There are other tests and treatments to be preceded
4. When CT or MRI shows organic abnormalities such as acute subdural hematoma, cerebral contusion and skull fracture, or when movement by walking is impossible
5. In the case of intracranial hemorrhage, a history of cerebral infarction or intracranial mass
6. Patients with a history of stroke or severe head trauma within 1 month
7. Patients with a history of major surgery, parturition, or serious trauma within 14 days
8. Patients with serious other organs and systemic complications
9. Other patients whose physicians in charge judged unsuitable for participation in this study
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Hidetaka
Middle name
Last name Onodera
Organization St. Marianna university school of medicine Yokohama city Seibu Hospital
Division name Neursurgery
Zip code 241-0811
Address 1197-1 Yasashi-cho, Asahi-ku, Yokohama, Japan
TEL 045-366-1111
Email dera@marianna-u.ac.jp

Public contact
Name of contact person
1st name Taigen
Middle name
Last name Sase
Organization St. Marianna university school of medicine
Division name Neurosurgery
Zip code 216-8511
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan
TEL 0449778111
Homepage URL
Email sasetaigen@marianna-u.ac.jp

Sponsor
Institute St. Marianna university school of medicine
Institute
Department

Funding Source
Organization no
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization St. Marianna university school of medicine
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki, Japan
Tel 0449778111
Email dera@marianna-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 聖マリアンナ医科大学

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 28 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 09 Month 01 Day
Date of IRB
2017 Year 08 Month 28 Day
Anticipated trial start date
2017 Year 09 Month 14 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 27 Day
Last modified on
2019 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033015

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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