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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name