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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021257
Receipt No. R000024503
Scientific Title Development of a novel facial nerve rehabilitation by the transcranial magnetic stimulation
Date of disclosure of the study information 2018/04/01
Last modified on 2016/02/29

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Basic information
Public title Development of a novel facial nerve rehabilitation by the transcranial magnetic stimulation
Acronym Facial nerve rehabilitation by the transcranial magnetic stimulation
Scientific Title Development of a novel facial nerve rehabilitation by the transcranial magnetic stimulation
Scientific Title:Acronym Facial nerve rehabilitation by the transcranial magnetic stimulation
Region
Japan

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

Objectives
Narrative objectives1 Assessing the effect of the transcranial magnetic stimulation on the facial nerve palsy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Scores by the facial nerve grading system (Yanagihara's score, Scores by Sunnybrook facial grading system and House-Brackmann grading system)
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Facial nerve rehabilitation by the transcranial magnetic stimulation
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 The person who is more than 20 and less than 70 years old.
2 10 or lower Yanagihara score and/or 15% of lower ENoG value
3 The person who can take the protocol treatment 8 weeks after two to 11 months later after the onset.
4 The person who can come to the hospital up to 2 months after the onset
Key exclusion criteria 1) Being , or planning to be registered to other clinical trials during the period of this clinical trial.
2) Being treated or planning to be treated by other treatment methods which significantly affect to the facial movement, such as electric stimulation on the face, facial nerve block, acupuncture.
3) Performance status 3 or higher
4) Diaabetes (HbA1c > 6.5%).
5) Neurological disorders with facial palsy.
6) History of clinically significant intracranial abnormalities.
7) Implantation of following devices a) aneurysm clip b) Cardiac catheter
8) Significantly increased intracranial pressure
Target sample size 60

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

Sponsor
Institute Dept. of Otolaryngology, Graduate School of Medical Sciences, Nagoya City University
Institute
Department

Funding Source
Organization Scientific Grant in Aids (KAKENHI)
Organization
Division
Category of Funding Organization
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

Management information
Registered date
2016 Year 02 Month 29 Day
Last modified on
2016 Year 02 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024503

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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