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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033566
Receipt No. R000038273
Scientific Title The effect of transcranial direct current stimulation on non-dominant hand motor performance in healthy adults
Date of disclosure of the study information 2018/08/01
Last modified on 2018/07/30

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Basic information
Public title The effect of transcranial direct current stimulation on non-dominant hand motor performance in healthy adults
Acronym The effect of transcranial direct current stimulation on non-dominant hand motor performance in healthy adults
Scientific Title The effect of transcranial direct current stimulation on non-dominant hand motor performance in healthy adults
Scientific Title:Acronym The effect of transcranial direct current stimulation on non-dominant hand motor performance in healthy adults
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose is to examine the effect of transcranial direct current stimulation on non-dominant hand motor performance in healthy adults
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Chopstick task with non-dominant hand
Key secondary outcomes Jebsen-Taylor Hand Function Test with non-dominant hand

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved 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 transcranial direct current stimulation (tDCS) over the primary motor cortex (20 min)
Interventions/Control_2 sham stimulation over the primary motor cortex
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.right-handed healthy adults
2.Individuals without a neurological or psychiatric history
3.Capability of informed consent based on their own decision
Key exclusion criteria 1.Individuals with a history of head trauma
2.Individuals with a history of organic brain disease
3.Individuals with a history or current history of substance dependence
4.Individuals who are taking central nervous system stimulants
5.Individuals who have a history of disorders of consciousness and/or seizure
6.Individuals who have a chronic headache
7.Individuals who are unable to undergo tDCS
8.Individuals that researchers decide that they are inappropriate for study participation.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Reiji Kato
Organization Hamamatsu City Rehabilitation Hospital
Division name Division of Rehabilitation
Zip code
Address 1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
TEL 053-471-8331
Email re-kato@sis.seirei.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Reiji Kato
Organization Hamamatsu City Rehabilitation Hospital
Division name Division of Rehabilitation
Zip code
Address 1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
TEL 053-471-8331
Homepage URL
Email re-kato@sis.seirei.or.jp

Sponsor
Institute Hamamatsu City Rehabilitation Hospital
Institute
Department

Funding Source
Organization Hamamatsu City Rehabilitation Hospital
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
Email

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 浜松市リハビリテーション病院

Other administrative information
Date of disclosure of the study information
2018 Year 08 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 05 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 30 Day
Last modified on
2018 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038273

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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