UMIN-CTR Clinical Trial

Basic information
Public title	Relationships between musical functions, clinical symptoms and brain function in patients with stroke
Acronym	Relationships between musical functions, clinical symptoms and brain function in patients with stroke
Scientific Title	Relationships between musical functions, clinical symptoms and brain function in patients with stroke
Scientific Title:Acronym	Relationships between musical functions, clinical symptoms and brain function in patients with stroke
Region	Japan

Condition
Condition	stroke, healthy control
Classification by specialty	Neurology Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate relationships between musical functions, clinical symptoms and brain activity in patients with stroke
Basic objectives2	Others
Basic objectives -Others	cross-sectional study
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluations of musical functions
Key secondary outcomes	motor functions, cognitive deficits, MRI, NIRS

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	Evaluations of musical functions Evaluations of motor and cognitive impairments MRI NIRS
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)first ever stroke, or recurrent stroke within the same hemisphere 2) more than one month from the onset 3) seating endurance of one hour
Key exclusion criteria	1) serious medical conditions 2) severe cognitive deficits not to understand research plan 3) motor impairment on the unaffected upper limb 4) visual and hearing impairments that preclude evaluations of musical functions 5) skull defects
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Keiichiro Middle name Last name Shindo
Organization	Shonan Keiiku Hospital
Division name	Department of rehabilitation medicine
Zip code	252-0816
Address	4360 Endo, Fujisawa city, Kanagawa Prefecture
TEL	0466-48-0050
Email	krugreims@yahoo.co.jp

Public contact
Name of contact person	1st name Keiichiro Middle name Last name Shindo
Organization	Shonan Keiiku Hospital
Division name	Department of rehabilitation medicine
Zip code	252-0816
Address	4360 Endo, Fujisawa city, Kanagawa Prefecture
TEL	0466-48-0050
Homepage URL
Email	krugreims@yahoo.co.jp

Sponsor
Institute	Shonan Keiiku Hospital
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethics committee of Shonan Keiiku Hospital
Address	4360 Endo, Fujisawa-city, Kanagawa
Tel	0466-48-0050
Email	K-miyazaki@keiiku.gr.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	2019 Year 01 Month 16 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	34
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	2018 Year 12 Month 13 Day
Date of IRB	2018 Year 12 Month 20 Day
Anticipated trial start date	2019 Year 01 Month 07 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2019 Year 01 Month 16 Day
Last modified on	2020 Year 04 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040507