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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042821
Receipt No. R000048886
Scientific Title Auditory steady-state evoked response by bone conduction ultrasound in normal subject
Date of disclosure of the study information 2021/01/04
Last modified on 2020/12/22

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Basic information
Public title Auditory steady-state evoked response by bone conduction ultrasound in normal subject
Acronym Auditory steady-state evoked response by bone conduction ultrasound in normal subject
Scientific Title Auditory steady-state evoked response by bone conduction ultrasound in normal subject
Scientific Title:Acronym Auditory steady-state evoked response by bone conduction ultrasound in normal subject
Region
Japan

Condition
Condition Normal subject
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Physiological mechanism of bone conduction ultrasound
Basic objectives2 Others
Basic objectives -Others Hemodynamics of bone conduction ultrasound
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes EEG
Key secondary outcomes Near-infrared spectroscopy

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
Other
Interventions/Control_1 Ultrasound
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
18 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1) Normal hearing
2) Normal cognitive function
3) Age 18-65 years old
Key exclusion criteria 1) evidence of previous dementia or mental illness,
2) pregnant woman,
3) contraindications for an MRI scan: heart pacemaker, patients who have a metallic foreign body (metal sliver) in their eye or in their brain,
5) contraindications for the ultrasound
6) subjects refused to participate in the study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Shibata
Organization University of Toyama
Division name Department of Neurosurgery
Zip code 9300194
Address 2630 Sugitani, Toyama
TEL +81-76-434-7348
Email sibata@med.u-toyama.ac.jp

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Shibata
Organization University of Toyama
Division name Department of Neurosurgery
Zip code 9300194
Address 2630 Sugitani, Toyama
TEL +81-76-434-7348
Homepage URL
Email sibata@med.u-toyama.ac.jp

Sponsor
Institute University of Toyama
Institute
Department

Funding Source
Organization Others
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Center for Clinical Research
Address 2630 Sugitani, Toyama
Tel 076-434-7152
Email chiken@med.u-toyama.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
2021 Year 01 Month 04 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
2019 Year 07 Month 03 Day
Date of IRB
2020 Year 12 Month 22 Day
Anticipated trial start date
2019 Year 07 Month 03 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 12 Month 22 Day
Last modified on
2020 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048886

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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