UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021257 |
|---|---|
| Receipt number | 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 21:35:19 |
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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
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
meijo_ent@hotmail.com
Sponsor or person
Institute
Dept. of Otolaryngology, Graduate School of Medical Sciences, Nagoya City University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024503
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
