UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Facial-Hypoglossal neural network system construction for the patients of imcomplete recovery of facial palsy
Title of the study (Brief title)	Facial-Hypoglossal Neural Network System Construction
Region	Japan

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

Objectives
Narrative objectives1	Assessment of safety and efficacy of the Facial-Hypoglossal Neural Network System Construction surgery
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Assessment of movement of facial muscles using Yanagihara facial nerve grading system, House-Brackmann scale and Sunny-brook scale at 1, 3, 6, 9 and 12 months after surgery.
Key secondary outcomes	Assessment of tongue moving. Adverse event of surgery. Assessment of QOL about facial movement using questionnaire.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Surgery (Network reconstruction of facial nerve) We connect facial nerve to hypoglossal nerve using great auricular nerve or sural nerve. We can use hypoglossal nerve itself or ansa cervicalis nerve which is a branch of hypoglossal nerve.
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Six months after developing facial palsy 2. Incomplete recovery, as score of <36 points with Yanagihara facial nerve grading system. 3. No history of cervical surgery. 4. Written informed consent was obtained from the patient.
Key exclusion criteria	Except inclusion criteria
Target sample size	20

Research contact person
Name of lead principal investigator	Koichiro Wasano
Organization	Japanese Red Cross Shizuoka Hospital
Division name	Department of Otolaryngology
Address	8-2 Outemachi, Aoi-ku, Shizuoka Japan
TEL	+81-54-254-4311
Email	wasano@a5.keio.jp

Public contact
Name of contact person	Koichiro Wasano
Organization	Japanese Red Cross Shizuoka Hospital
Division name	Department of Otolaryngology
Address	8-2 Outemachi, Aoi-ku, Shizuoka Japan
TEL	+81-54-254-4311
Homepage URL
Email	wasano@a5.keio.jp

Sponsor
Institute	Japanese Red Cross Shizuoka Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	静岡赤十字病院、済生会宇都宮病院、国立病院機構東京医療センター

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 16 Day
Anticipated trial start date	2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 23 Day
Last modified on	2016 Year 04 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024881