UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033929 |
|---|---|
| Receipt number | R000038689 |
| Scientific Title | Efficacy and safety of transcranial direct current stimulation in acute ischemic stroke |
| Date of disclosure of the study information | 2018/10/01 |
| Last modified on | 2021/05/02 19:28:52 |
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Basic information
Public title
Efficacy and safety of transcranial direct current stimulation in acute ischemic stroke
Acronym
Efficacy and safety of transcranial direct current stimulation in acute ischemic stroke
Scientific Title
Efficacy and safety of transcranial direct current stimulation in acute ischemic stroke
Scientific Title:Acronym
Efficacy and safety of transcranial direct current stimulation in acute ischemic stroke
Region
| Japan |
Condition
Condition
ischemic stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of transcranial direct current stimulation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment(FMA)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
twenty-daily sessions of tDCS (n = 10) in 4 weeks.
Interventions/Control_2
twenty-daily sessions of sham stimulation (n =10) in 4 weeks.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria were:
(1) Age 18-80
(2) Clinical first ever ischemic cerebrovascular stroke confirmed by MRI
(3) Acute phase of stroke (after 1 week after the stroke onset).
Key exclusion criteria
(1) Pre-stroke disability
(2) Coexistent neurological or psychiatric disease (including epilepsy) as to decrease number of confounders
(3) History of significant alcohol or drug abuse
(4) Use of neuropsychotropic drugs, such as antidepressants or benzodiazepines.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuroda |
Organization
University of Toyama
Division name
Department of Neurosurgery
Zip code
9300194
Address
sugitani toyama
TEL
0764347348
skuroda@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Shibata |
Organization
University of Toyama
Division name
Department of Neurosurgery
Zip code
9300194
Address
2630 sugitani toyama
TEL
0764347348
Homepage URL
sibata@dj8.so-net.ne.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
No Funding source
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
University of Toyama
Address
2630 sugitani Toyama
Tel
0764347348
sibata@dj8.so-net.ne.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
| 2018 | Year | 10 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 10 | 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
| 2018 | Year | 08 | Month | 28 | Day |
Last modified on
| 2021 | Year | 05 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038689
