UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028012 |
|---|---|
| Receipt number | R000032073 |
| Scientific Title | Influence of brain activation by transcranial direct current electrical stimulation on sensation of the hand |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2019/05/08 20:36:22 |
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Basic information
Public title
Influence of brain activation by transcranial direct current electrical stimulation on sensation of the hand
Acronym
Influence of hand sensation by transcranial direct current electrical stimulation
Scientific Title
Influence of brain activation by transcranial direct current electrical stimulation on sensation of the hand
Scientific Title:Acronym
Influence of hand sensation by transcranial direct current electrical stimulation
Region
| Japan |
Condition
Condition
There are no target diseases
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is for healthy subjects to investigate whether tDCS affects the sense of the hand and what impact it will have if it affects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The current perception threshold and the pain corresponding current value obtained by PainVision before and after electrical stimulation are compared between conditions. Also, the pain index calculated from the current perception threshold and the corresponding current, and the pain level are compared between conditions.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
The primary motor cortex is stimulated by tDCS for 15 minutes. The type of stimulation of tDCS are three types of of anodal stimulation, cathodal stimulation, sham stimulation.
Interventions/Control_2
The primary somatosensory cortex is stimulated by tDCS for 15 minutes. The type of stimulation of tDCS are three types of of anodal stimulation, cathodal stimulation, sham stimulation.
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
1,Healthy adults aged 20 years or older who had posted on this facility (within the Hiroshima University Kasumi Campus) and had a proposal to participate in this research as a research participant recruitment
2.Person who obtains consent in writing on participation of this research
Key exclusion criteria
1.Persons who have a history / merger of neurological disorder, mental illness
2.Persons with disabilities in cognitive functions
3.Persons who have skin disorder where electrodes can not be attached to fingers
4.Those with interests with researchers and research managers (including those who may be lectured by researchers)
5.Other persons who have judged that it is inappropriate for the Research Director or Research Assignee to implement this research
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Sunagawa |
Organization
Hiroshima University Graduate School of Biomedical & Health Sciences
Division name
Laboratory of analysis & control of upper extremity function
Zip code
Address
1-2-3 Kasumi,Minami-ku, Hiroshima
TEL
082-257-5455
torusuna@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akio Ueda |
Organization
Hiroshima University Graduate School of Biomedical & Health Sciences
Division name
Laboratory of analysis & control of upper extremity function
Zip code
Address
1-2-3 Kasumi,Minami-ku, Hiroshima
TEL
082-257-5455
Homepage URL
d166430@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Graduate School of Biomedical & Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Japan science and technology agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 07 | 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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2017 | Year | 06 | Month | 30 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032073
| 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 |
