UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021230 |
|---|---|
| Receipt number | R000024489 |
| Scientific Title | Evaluation of the facial nerve palsy by functional magnetic resonance imaging |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2016/02/27 17:47:55 |
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Basic information
Public title
Evaluation of the facial nerve palsy by functional magnetic resonance imaging
Acronym
Evaluation of the facial nerve palsy by functional magnetic resonance imaging
Scientific Title
Evaluation of the facial nerve palsy by functional magnetic resonance imaging
Scientific Title:Acronym
Evaluation of the facial nerve palsy by functional magnetic resonance imaging
Region
| Japan |
Condition
Condition
facial nerve palsy
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the correlation between the prognosis of facial nerve palsy and images of functional magnetic resonance imaging
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate the correlation between the weight center and size of the high density area, and facial nerve palsy score.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients who has severe facial palsy (Yanagihara score <10) or 15% or less ENoG or blink reflex
2) Patients who are 20 years old or older and younger than 70 years old with his or her written consent.
3) Patients who can have the first and second MRI study 2 to 11 months after the onset
4) Patient who can come to the clinic every two months
Key exclusion criteria
1) The patients who received or are planning to receive treatments such as nerve block, acupuncture or other treatment specified.
2) History of neurological or psychological disorders other than facial palsy
3) Abnormal findings on head CT or MRI
4) Has a history of ipsilateral or dorsolateral facial palsy
5) History of diabetes
6) Cochlear implant or other implantable devices with metal parts
7) Profound hearing loss
8) Performance status 3 or higher
9) Patients who cannot provide a written consent.
10) Pregnant woman
11) When the investigators considered as being not eligible
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Murakami |
Organization
Nagoya City University Hospital
Division name
Department of Otolaryngology
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-Ku, Nagoya City, Japan
TEL
052-853-8256
meijo_ent@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Inagaki |
Organization
Nagoya City University Hospital
Division name
Department of Otolaryngology
Zip code
Address
1 Kawasumi, Mizuho-cho, Mizuho-Ku, Nagoya City, Japan
TEL
052-853-8256
Homepage URL
meijo_ent@hotmail.com
Sponsor or person
Institute
Department of Otolaryngology, Nagoya City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Magnetic Health Science Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
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 | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 07 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 08 | 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
Analyze the relationship between facial nerve palsy score and weighted center, size of the high density area on fMRI
Management information
Registered date
| 2016 | Year | 02 | Month | 27 | Day |
Last modified on
| 2016 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024489
