UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013991 |
|---|---|
| Receipt number | R000016299 |
| Scientific Title | The effect of Japanese version of melodic intonation therapy to aphasia: an fMRI study |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2022/05/26 12:04:46 |
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Basic information
Public title
The effect of Japanese version of melodic intonation therapy to aphasia: an fMRI study
Acronym
Japanese version of MIT for aphasia
Scientific Title
The effect of Japanese version of melodic intonation therapy to aphasia: an fMRI study
Scientific Title:Acronym
Japanese version of MIT for aphasia
Region
| Japan |
Condition
Condition
patients with aphasia
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of Japanese version of MIT
Basic objectives2
Others
Basic objectives -Others
To investigate the mechanism of MIT
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Western Aphasia Battery (WAB)
Key secondary outcomes
Images of fMRI
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
Speech training using Japanese version of MIT
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Over 6 months after the onset of aphasia
2.Stable physical and mental condition to do the speech training
Key exclusion criteria
1.Bad physical and mental condition
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Satoh |
Organization
Graduate School of Medicine, Mie University
Division name
Dementia Prevention and Therapeutics
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-6031
bruckner@clin.medic.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Satoh |
Organization
Graduate School of Medicine, Mie University
Division name
Dementia Prevention and Therapeutics
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie
TEL
059-231-6031
Homepage URL
bruckner@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Dementia Prevention and Therapeutics, Graduate School of Medicine, Mie University
Institute
Department
Personal name
Funding Source
Organization
Dementia Prevention and Therapeutics, Graduate School of Medicine, Mie University
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
Graduate School of Medicine, Mie University
Address
Edobashi 2-174, Tsu,Mie, Japan
Tel
0592316031
bruckner@clin.medic.mie-u.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
| 2014 | Year | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2014 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | 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
| 2014 | Year | 05 | Month | 19 | Day |
Last modified on
| 2022 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016299
