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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031479
Receipt No. 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 2018/06/11

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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
Middle name
Last name Tetsuaki Kawase
Organization Tohoku University
Division name Graduate School of Biomedical Engineering
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
Division name Graduate School of Biomedical Engineering
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 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
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
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
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 Open public recruiting
Date of protocol fixation
2018 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 01 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
2018 Year 02 Month 26 Day
Last modified on
2018 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035934

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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