UMIN-CTR Clinical Trial

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
Email	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
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	Tohoku University Graduate School of Medicine Ethics Committee
Address	1-1 Seiryo-machi, Aoba-ku
Tel	022-717-8007
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035934