UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042821 |
|---|---|
| Receipt number | 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 | 2021/05/02 19:31:16 |
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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
sibata@dj8.so-net.ne.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
ssibata@dj8.so-net.ne.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
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
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
| 2021 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048886
