UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019198 |
|---|---|
| Receipt number | 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 12:38:45 |
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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
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
kawase@orl.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022179
| Research Plan | |
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| 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 |
