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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000036353
Receipt No. R000041416
Scientific Title Relationship between Kynurenine Pathway related biomarkers and stroke recovery
Date of disclosure of the study information 2019/03/30
Last modified on 2019/03/30

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Basic information
Public title Relationship between Kynurenine Pathway related biomarkers and stroke recovery
Acronym Kynurenine Pathway related biomarkers and stroke recovery
Scientific Title Relationship between Kynurenine Pathway related biomarkers and stroke recovery
Scientific Title:Acronym Kynurenine Pathway related biomarkers and stroke recovery
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Our purpose was to investigate the effects of rTMS on serum levels of Kynurenine Pathway related biomarkers in post-stroke patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes change of serum levels of Kynurenine Pathway related biomarkers
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 rehabilitation with repetitive transcranial magnetic stmulation(2weeks)
Interventions/Control_2 rehabilitation without repetitive transcranial magnetic stmulation(2weeks)
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
30 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) Age at intervention of 30-90 years.
2) Time after onset of stroke >1 month.
3) Mild or moderate upper limb hemiparesis
4) At a probable plateau state with regard to recovery of upper limb hemiparesis
5) No cognitive deficits
6) No history of convulsions.
7) No intracranial metal or cardiac pacemaker.
Key exclusion criteria 1) Unacceptable quality of blood samples collected from the patients
2) missing values of clinical evaluation before and/or after intervention.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Masachika
Middle name
Last name Niimi
Organization The Jikei University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code 105-8461
Address 3-25-8, Nishi-Shimbashi, Minato-Ku, Tokyo
TEL 03-3433-1111
Email pomardon2010@gmail.com

Public contact
Name of contact person
1st name Masachika
Middle name
Last name Niimi
Organization The Jikei University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code 105-8461
Address 3-25-8, Nishi-Shimbashi, Minato-Ku, Tokyo
TEL 03-3433-1111
Homepage URL
Email pomardon2010@gmail.com

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization This work was supported by JSPS KAKENHI Grant Number 17K13070.
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Jikei University Certified Review Board
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
Tel 03-3433-1111
Email crb@jikei.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
2019 Year 03 Month 30 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 95
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
2011 Year 12 Month 05 Day
Date of IRB
2011 Year 12 Month 05 Day
Anticipated trial start date
2012 Year 02 Month 01 Day
Last follow-up date
2019 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
2019 Year 03 Month 30 Day
Last modified on
2019 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041416

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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