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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021227
Receipt No. R000024487
Scientific Title Refinement of facial Rehabilitation for facial palsy patients with Transcranial Magnetic Stimulation
Date of disclosure of the study information 2017/09/01
Last modified on 2016/02/27

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Basic information
Public title Refinement of facial Rehabilitation for facial palsy patients with Transcranial Magnetic Stimulation
Acronym Refinement of facial Rehabilitation for facial palsy patients
Scientific Title Refinement of facial Rehabilitation for facial palsy patients with Transcranial Magnetic Stimulation
Scientific Title:Acronym Refinement of facial Rehabilitation for facial palsy patients
Region
Japan

Condition
Condition Facial nerve palsy
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Refinement of facial Rehabilitation for facial palsy patients with Transcranial Magnetic Stimulation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Compare the facial nerve palsy scores between the groups with and without intervention
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Rehabilitation with transcranial magnetic stimulation and systemic steroids treatment
Interventions/Control_2 Standard systemic steroids treatment
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 The patients who can start the protocol between 2 to 11 months after the onset of the facial palsy, who can submit a written consent, who can consent to be followed up until 13 months after the onset or reaching to the plateau phase in terms of facial movement.

Key exclusion criteria The patient with intracranial lesions, diabetes, or PS3 or higher
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shingo Murakami
Organization Nagoya City University Hospital
Division name Dept. of Otolaryngology
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL 052-853-8257
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 Dept of Otolaryngology
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya Japan
TEL 052-853-8256
Homepage URL
Email meijo_ent@hotmail.com

Sponsor
Institute Department of Otolaryngology, Nagoya City University
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
2017 Year 09 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 09 Month 30 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
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=R000024487

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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