UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023812 |
|---|---|
| Receipt number | 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 12:51:52 |
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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
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
saya-55@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo college of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026972
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
