UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011444 |
|---|---|
| Receipt number | R000013396 |
| Scientific Title | Before-after study of a transcranial direct current stimulation (tDCS) effects for rehabilitative treatments in subacute brain damaged patients |
| Date of disclosure of the study information | 2013/08/11 |
| Last modified on | 2016/12/26 09:27:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Before-after study of a transcranial direct current stimulation (tDCS) effects for rehabilitative treatments in subacute brain damaged patients
Acronym
Effects of a transcranial direct current stimulation (tDCS) in rehabilitative treatments
Scientific Title
Before-after study of a transcranial direct current stimulation (tDCS) effects for rehabilitative treatments in subacute brain damaged patients
Scientific Title:Acronym
Effects of a transcranial direct current stimulation (tDCS) in rehabilitative treatments
Region
| Japan |
Condition
Condition
Cerebrovascular disease, Traumatic brain injury
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of a transcranial direct current stimulation on rehabilitative task achievement in subacute brain damaged patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rehabilitative task achievement: 1) Higher brain disorders; Clinical assessment for attention, Naming task, 2) Motor palsy; Dexterity, Ankle movement, Standing balance, 3) Dysphagia; Swallowing reflex velocity
Key secondary outcomes
Effects on learning skills (Digit span, Tapping span, Repetitive tests of body sways), Safety (Questionnaire surveying for tDCS adverse effects)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Transcranial direct current stimulation (2mA intensity for 20 minutes once a day for 5 consecutive days)
Interventions/Control_2
Sham transcranial direct current stimulation (20 minutes once a day for 5 consecutive days)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted for cerebrovascular disease or traumatic brain injury treatments within 2 months and required rehabilitative treatments to higher brain disorders such as inattention and aphasia, motor palsy, or dysphagia.
Key exclusion criteria
Brain surgery to the tDCS stimulation sites,
History of seizure,
History of other brain diseases,
Epicardial pacemaker implantation
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimitaka Hase |
Organization
Kansai Medical University Hirakata Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
2-3-1 Shinmachi, Hirakata, Osaka
TEL
072-804-2780
hasekim@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimitaka Hase |
Organization
Kansai Medical University Hirakata Hospital
Division name
Department of Rehabilitation Medicine
Zip code
Address
hasekim@hirakata.kmu.ac.jp
TEL
072-804-2780
Homepage URL
hasekim@hirakata.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Hirakata Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
関西医科大学附属枚方病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www7.kmu.ac.jp/rehab/research/
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
Terminated
Date of protocol fixation
| 2013 | Year | 05 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 12 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 25 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 26 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 26 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 10 | Day |
Last modified on
| 2016 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013396
