UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033566 |
|---|---|
| Receipt number | 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 | 2020/03/14 20:17:03 |
* 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
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
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
re-kato@sis.seirei.or.jp
Sponsor or person
Institute
Hamamatsu City Rehabilitation Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038273
