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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023812
Receipt No. R000026972
Scientific Title Clinical trial to evaluate the efficacy of transcranial Direct Current Stimulation in chronic stroke patients.
Date of disclosure of the study information 2016/12/01
Last modified on 2016/08/29

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Basic information
Public title Clinical trial to evaluate the efficacy of transcranial Direct Current Stimulation in chronic stroke patients.
Acronym Clinical trial to evaluate the efficacy of transcranial Direct Current Stimulation in chronic stroke patients.
Scientific Title Clinical trial to evaluate the efficacy of transcranial Direct Current Stimulation in chronic stroke patients.
Scientific Title:Acronym Clinical trial to evaluate the efficacy of transcranial Direct Current Stimulation in chronic stroke patients.
Region
Japan

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

Objectives
Narrative objectives1 Effects of transcranial Direct Current Stimulation in chronic stroke patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stroke Impairment Assessment Set
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 transcranial direct current stimulation(2mA intensity for 20 minutes once a day)
Standard rehabilitation
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

Not applicable
Gender Male and Female
Key inclusion criteria chronic-stage stroke patient (6 months or more after onset)
Key exclusion criteria 1)epilepsy
2)permanent pacemaker, cochlear implant
3)skull or spinal implant
4)arthroplasty of upper limb
5)consciousness disturbance, advanced dementia or communicative difficulties
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Domen
Organization Hyogo college of medicine
Division name Department of Rehabilitation medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6881
Email saya-55@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sayaka Ikeda
Organization Hospital of Hyogo college of medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL 0798-45-6881
Homepage URL
Email saya-55@hyo-med.ac.jp

Sponsor
Institute Hyogo college of medicine
Institute
Department

Funding Source
Organization non
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
Address
Tel
Email

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
2016 Year 12 Month 01 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
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 Preinitiation
Date of protocol fixation
2016 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 29 Day
Last modified on
2016 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026972

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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