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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000019198
Receipt No. R000022179
Scientific Title 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
Date of disclosure of the study information 2015/10/15
Last modified on 2017/04/01

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Basic information
Public title 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
Acronym Neuromagnetic assessments of electrical stimulation of the reconstructed skin flap
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Tetsuaki Kawase
Organization Tohoku University Graduate School of Biomedical Engineering / Graduate School of Medicine
Division name audiology
Zip code
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
1st name
Middle name
Last name Tetsuaki Kawase
Organization Tohoku University Graduate School of Biomedical Engineering / Graduate School of Medicine
Division name audiology
Zip code
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)

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
2015 Year 10 Month 15 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
Terminated
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 Terminated
Date of protocol fixation
2015 Year 10 Month 01 Day
Date of IRB
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

Other
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

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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