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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028012 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | There are no target diseases | |
Classification by specialty |
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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 |
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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 | ||
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Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Hiroshima University Graduate School of Biomedical & Health Sciences |
Institute | |
Department |
Funding Source | |
Organization | Japan science and technology agency |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization |
Other related organizations | |
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IRB Contact (For public release) | |
Organization | |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032073 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |