UMIN-CTR Clinical Trial

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 Reiji Middle name Last name Kato
Organization	Hamamatsu City Rehabilitation Hospital
Division name	Division of Rehabilitation
Zip code	433-8127
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 Reiji Middle name Last name Kato
Organization	Hamamatsu City Rehabilitation Hospital
Division name	Division of Rehabilitation
Zip code	433-8127
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	Hamamatsu City Rehabilitation Hospital
Address	1-6-1 Wagoukita Hamamatsu, Shizuoka, JAPAN
Tel	053-471-8331
Email	re-kato@sis.seirei.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	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	12
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	2018 Year 05 Month 01 Day
Date of IRB	2018 Year 05 Month 01 Day
Anticipated trial start date	2018 Year 07 Month 15 Day
Last follow-up date	2019 Year 03 Month 30 Day
Date of closure to data entry	2019 Year 03 Month 30 Day
Date trial data considered complete	2019 Year 03 Month 30 Day
Date analysis concluded	2019 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date	2018 Year 07 Month 30 Day
Last modified on	2020 Year 03 Month 14 Day

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