UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032120 |
|---|---|
| Receipt number | R000036644 |
| Scientific Title | Exploratory study on the usefulness of functional MRI and Ophthalmic ultrasound to the diagnosis and prognostic prediction of prolonged consciousness disturbance |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2018/04/05 16:10:46 |
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Basic information
Public title
Exploratory study on the usefulness of functional MRI and Ophthalmic ultrasound to the diagnosis and prognostic prediction of prolonged consciousness disturbance
Acronym
Exploratory study on the usefulness of functional MRI and Ophthalmic ultrasound to the diagnosis and prognostic prediction of prolonged consciousness disturbance
Scientific Title
Exploratory study on the usefulness of functional MRI and Ophthalmic ultrasound to the diagnosis and prognostic prediction of prolonged consciousness disturbance
Scientific Title:Acronym
Exploratory study on the usefulness of functional MRI and Ophthalmic ultrasound to the diagnosis and prognostic prediction of prolonged consciousness disturbance
Region
| Japan |
Condition
Condition
Patient diagnosed as impaired consciousness that prolonged 48 hours or more after entering intensive care unit (ICU)
Classification by specialty
| Neurology | Anesthesiology | Emergency medicine |
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the usefulness of functional differential magnetic resonance imaging (fMRI) image inspection and ophthalmic ultrasonic examination as a differential diagnostic tool for prolonged consciousness disturbance or prognostic prediction index exploratory.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neurological function as of 28th (CRS-R, GOS-E scoring value)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Neural image evaluation after 72 hours (whole brain activation fMRI, resting f MRI, diffusion weighted imaging method, three dimensional high definition anatomical imaging, cerebral reflux MRI) and ophthalmic ultrasound; optic nerve sheath diameter
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient who has consciousness disorder that prolongs more than 48 hours after entering ICU
2) Patients aged 20 years or older at the time of acquiring consent (regardless of gender)
3) After receiving sufficient explanation for the participation of this study, patients who obtained written agreement from the patient himself or a substitute
Key exclusion criteria
1) Patients who can not image MRI
2) Patients with traumatic brain injury
3) Patients during sedation drug administration
4) Women who may be pregnant or have a possibility of pregnancy
5) Women who are breastfeeding
6) In addition, patients who are deemed inappropriate as research subjects by research managers
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Ota |
Organization
Shonan Kamakura General Hospital
Division name
Anesthesiology
Zip code
Address
Kamakura city, Okamoto 1370-1, Kanagawa, Japan
TEL
0467-46-1717
otacchi@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Ota |
Organization
Shonan Kamakura General Hospital
Division name
Anesthesiology
Zip code
Address
Kamakura city, Okamoto 1370-1, Kanagawa, Japan
TEL
0467-46-1717
Homepage URL
otacchi@gmail.com
Sponsor or person
Institute
Shonan Kamakura General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 05 | Day |
Last modified on
| 2018 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036644
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
