UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031479 |
|---|---|
| Receipt number | R000035934 |
| Scientific Title | Study on establishment of normal data of auditory evoked field in response to click stimulation |
| Date of disclosure of the study information | 2018/02/26 |
| Last modified on | 2021/01/28 16:03:56 |
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Basic information
Public title
Study on establishment of normal data of auditory evoked field in response to click stimulation
Acronym
auditory evoked field in response to click stimulation
Scientific Title
Study on establishment of normal data of auditory evoked field in response to click stimulation
Scientific Title:Acronym
auditory evoked field in response to click stimulation
Region
| Japan |
Condition
Condition
normal subjects
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1) P50 sensory gating and 2) masking level difference are measured using a magnetoencephalography to establish normal data in the facility
Basic objectives2
Others
Basic objectives -Others
Evaluation of characteristics of normal response
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amplitude ratio of auditory evoked field P50m (P50m sensory gating)
Key secondary outcomes
Amplitude of auditory steady state responses measured with auditory evoked field (masking level difference)
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
measurements of auditory evoked fields
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Normal subjects with Performance state 0
(2) 20 <= age < 40
Key exclusion criteria
(1) Persons who have a history of peripheral or central nervous disease
(2) Persons who have a history of ear diseases
(3) Persons who have a history of mental illness
(4) Persons wearing cardiac pacemakers and/or implantable defibrillators
(5) Persons with metals in the body (cerebral aneurysm clips, bolts and plates after fracture treatment, orthodontic treatment, within 1 month after hair dyeing, tattoo etc.)
(6) Claustrophobia and/or Nyctophobia
(7) Possible ppregnabcey
(8) Persons with extreme myopia
(9) Those who are wearing clothing for cold weather using new materials (for example, Heat Tech etc.)
(10) Other persons who who have judged that they are inappropriate as subjects
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tetsuaki |
| Middle name | |
| Last name | Kawase |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8574
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 | Tetsuaki |
| Middle name | |
| Last name | Kawase |
Organization
Tohoku University
Division name
Graduate School of Biomedical Engineering
Zip code
980-8574
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
the Ministry of Education, Culture, Sports, Science and Technology-Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Graduate School of Medicine Ethics Committee
Address
1-1 Seiryo-machi, Aoba-ku
Tel
022-717-8007
med-kenkyo@grp.tohoku.ac.jp
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 | 02 | Month | 26 | 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
0
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
Terminated
Date of protocol fixation
| 2018 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 26 | Day |
Last modified on
| 2021 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035934
