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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034721
Receipt No. R000039587
Scientific Title Efficacy and safety of transcranial direct current stimulation in subacute ischemic stroke
Date of disclosure of the study information 2018/10/31
Last modified on 2019/05/08

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Basic information
Public title Efficacy and safety of transcranial direct current stimulation in subacute ischemic stroke
Acronym Efficacy and safety of transcranial direct current stimulation in subacute ischemic stroke
Scientific Title Efficacy and safety of transcranial direct current stimulation in subacute ischemic stroke
Scientific Title:Acronym Efficacy and safety of transcranial direct current stimulation in subacute 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 Electroencephalogram

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 ten-daily sessions of tDCS (n = 10) in 2 weeks.
Interventions/Control_2 ten-daily sessions of sham stimulation (n =10) in 2 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 month 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 40

Research contact person
Name of lead principal investigator
1st name Akio
Middle name
Last name Urata
Organization Toyama Prefectural Rehabilitation Hospital and Support Center for Children with Disabilities
Division name Rehabilitation
Zip code 9318517
Address 36 Shimoiino Toyama
TEL 076-438-2233
Email urata@toyama-reha.or.jp

Public contact
Name of contact person
1st name Shibata
Middle name
Last name Takashi
Organization University of Toyama
Division name Department of Neurosurgery
Zip code 9300194
Address 2630 sugitani toyama
TEL 0764347348
Homepage URL
Email sibata@med.u-toyama.ac.jp

Sponsor
Institute University of Toyama
Institute
Department

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 Toyama Prefectural Rehabilitation Hospital and Support Center for Children with Disabilities
Address 36 Shimoiino Toyama
Tel 076-438-2233
Email urata@toyama-reha.or.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 31 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 09 Month 01 Day
Date of IRB
2019 Year 09 Month 01 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2021 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 10 Month 31 Day
Last modified on
2019 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039587

Research Plan
Registered date File name
2018/10/31 iEEG研究実施計画書.pdf

Research case data specifications
Registered date File name
2018/10/31 同意書.pdf

Research case data
Registered date File name


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