UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046479 |
|---|---|
| Receipt number | R000053032 |
| Scientific Title | Rehabilitation of auditory agnosia by auditory stimulation: a feasibility study |
| Date of disclosure of the study information | 2021/12/27 |
| Last modified on | 2024/01/04 23:04:26 |
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Basic information
Public title
Rehabilitation of auditory agnosia by auditory stimulation: a feasibility study
Acronym
Rehabilitation of auditory agnosia by auditory stimulation: a feasibility study
Scientific Title
Rehabilitation of auditory agnosia by auditory stimulation: a feasibility study
Scientific Title:Acronym
Rehabilitation of auditory agnosia by auditory stimulation: a feasibility study
Region
| Japan |
Condition
Condition
auditory agnosia
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assess by auditory evoked potential and speech audiometry test
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
auditory evoked potential
Key secondary outcomes
speech audiometry test
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
We present a patient white noise or 1000-4000 Hz tone for 10ms to 30s. Interstimulus interval is 3ms to 30s, and stimulus duration is 2min to 8min for one time. The stimulus is presented between auditory evoked potential measurement. It is also presented 10 times per day, for 4-8 weeks, at home.
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Auditory agnosia patients by storoke, and auditory normal subjects aged 20-65 years old
Key exclusion criteria
none
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | UNAI |
Organization
Saiseikai higashikanagawa rehabilitation hospital
Division name
Clinical department
Zip code
221-0822
Address
1-13-10, Nishi-Kanawawa, Yokohama 221-0822, Japan
TEL
+81-45-324-3600
uniki16@yahoo.co.jp
Public contact
Name of contact person
| 1st name | haruki |
| Middle name | |
| Last name | MIURA |
Organization
Saiseikai higashikanagawa rehabilitation hospital
Division name
Clinical department
Zip code
221-0822
Address
1-13-10, Nishi-Kanawawa, Yokohama 221-0822, Japan
TEL
+81-45-324-3600
Homepage URL
miuraharuki@gmail.com
Sponsor or person
Institute
Saiseikai higashikanagawa rehabilitation hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Ethics Committee of Saiseikai higashikanagawa rehabilitation hospital
Address
1-13-10, Nishi-Kanawawa, Yokohama 221-0822, Japan
Tel
045-324-3600
h-ebata@higashikanagawa.saiseikai.or.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 | 12 | Month | 27 | 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
1
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
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 27 | 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
| 2021 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053032
