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

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 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


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

Value
https://center6.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