UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028848 |
|---|---|
| Receipt number | 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 | 2024/03/12 17:42:10 |
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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
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
sasetaigen@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna university school of medicine
Institute
Department
Personal name
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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
65
Results
Ocular motility examinations were conducted, and participants were assigned to either the good improvement group (improvement rate over 15%) or the minor improvement group (improvement rate under 15%). SCAT 5 was measured at two points, involving 13 men: eight in the good improvement group and five in the minor improvement group. Symptom number, symptom severity, single-leg stance, tandem stance, and total errors worsened in the minor improvement group.
Results date posted
| 2024 | Year | 03 | Month | 12 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Delay due to a lack of data on concussion patients caused by restrictions on activities and event postponements.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
none
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033015
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