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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021230
Receipt No. 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

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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
Email 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
Email meijo_ent@hotmail.com

Sponsor
Institute Department of Otolaryngology, Nagoya City University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024489

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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