UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on the magnetic fields evoked by the electrical stimulation of the tongue and facial skin in operated patients with head and neck cancer reconstructed with skin flap
Title of the study (Brief title)	Neuromagnetic assessments of electrical stimulation of the reconstructed skin flap
Region	Japan

Condition
Condition	head and neck cancer (operated)
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To elucidate the sensory mechanism of the recostructed skin flap
Basic objectives2	Others
Basic objectives -Others	elucidation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	electrical evoked magnetic fields
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	measuements of electrical evoked magnetic fields of the skin flap (the time required for measurements: 1-1.5 hours, the number of measurements: 1, time of measuremnets:after obtaining informed consent)
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1) 20 <= age < 80 2) patients with head and neck cancer operated using skin flap 3) possible somatosensory sensation by the mechanical stimulation of the skin flap 4) written informed consent
Key exclusion criteria	1) peripheral or central neurological diorders 2) past history of the mental disease 3) pacemaker or implanted defibrillator 4) metal in the body 5) claustrophobia or nyctophobia 6) possiblity of the pregnancy 7) severe myopia 8) thermal clothes with new material 7) possible participants whom it is judged to be inappropriate as a subjects
Target sample size	20

Research contact person
Name of lead principal investigator	Tetsuaki Kawase
Organization	Tohoku University Graduate School of Biomedical Engineering / Graduate School of Medicine
Division name	audiology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7303
Email	kawase@orl.med.tohoku.ac.jp

Public contact
Name of contact person	Tetsuaki Kawase
Organization	Tohoku University Graduate School of Biomedical Engineering / Graduate School of Medicine
Division name	audiology
Address	1-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7303
Homepage URL
Email	kawase@orl.med.tohoku.ac.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	Tohoku University
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

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 10 Month 01 Day
Anticipated trial start date	2015 Year 10 Month 15 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	Terminated
Other related information

Management information
Registered date	2015 Year 10 Month 01 Day
Last modified on	2017 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022179