UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036848 |
|---|---|
| Receipt number | R000041978 |
| Scientific Title | The effects of tDCS combined with attention on motor cortical plasticity and motor learning in healthy volunteers |
| Date of disclosure of the study information | 2019/05/25 |
| Last modified on | 2019/05/27 09:29:39 |
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Basic information
Public title
The effects of tDCS combined with attention on motor cortical plasticity and motor learning
Acronym
The effects of tDCS combined with attention
Scientific Title
The effects of tDCS combined with attention on motor cortical plasticity and motor learning in healthy volunteers
Scientific Title:Acronym
The effects of tDCS combined with attention
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aims to investigate whether anodal tDCS combined with attention to the hand could enhance the motor cortical plasticity and improve motor learning in healthy individuals
Basic objectives2
Others
Basic objectives -Others
Basic science research for clinical application
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Motor evoked potential (MEP)
Key secondary outcomes
Short-interval intracortical inhibition (SICI), intracortical facilitation (ICF), ballistic thumb movement task
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Anodal transcranial direct current stimulation(2 mA,10 min) is applied when participants paid attention to the hand
Interventions/Control_2
Anodal transcranial direct current stimulation (2 mA,10 min) is applied when participants paid attention to the sound
Interventions/Control_3
Anodal transcranial direct current stimulation (2 mA,10 min)is applied without participants attention to the hand and sound
Interventions/Control_4
Sham transcranial direct current stimulation(2 mA,30 s) is applied when participants paid attention to the hand
Interventions/Control_5
Sham transcranial direct current stimulation(2 mA,30 s) is applied when participants paid attention to the sound
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Agreement to participate in the study
Key exclusion criteria
1. Medical history of orthopedic disease of hand
2. Medical history of neurological disease
3. Implanted electronic pacing or defibrillation devices
4. Medical history of epilepsy and febrile convulsion (including family history)
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Tomofumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Yamagata Prefectural University of Health Sciences
Division name
Department of Physical Therapy
Zip code
9902212
Address
260 Kamiyanagi, Yamagata-shi, Yamagata, Japan
TEL
023-686-6611
tyamaguchi@yachts.ac.jp
Public contact
Name of contact person
| 1st name | Tomofumi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Yamagata Prefectural University of Health Sciences
Division name
Department of Physical Therapy
Zip code
990-2212
Address
260 Kamiyanagi, Yamagata-shi, Yamagata, Japan
TEL
023-686-6611
Homepage URL
tyamaguchi@yachts.ac.jp
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
This work is supported by grants from the Grants-in-Aid for Scientific Research(KAKENHI)
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
Tokyo Bay Rehabilitation Hospital
Address
4-1-1 Yatsu, Narashino-shi, Chiba, Japan
Tel
047-453-9000
shinsakai@wanreha.net
Secondary IDs
Secondary IDs
YES
Study ID_1
78-2
Org. issuing International ID_1
Tokyo Bay Rehabilitation Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
東京湾岸リハビリテーション病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 25 | 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
33
Results
The significant increases of MEP and the significant decrease of SICI was observed at least for 60 min after anodal tDCS only when participants paid attention to their hands. In contrast, no significant changes in ICF was observed in all conditions. In the experiment 2, the combination of tDCS and attention to the hand significantly enhanced the acquisition of ballistic thumb movement. The higher performance was retained 7 days after the stimulation.
Results date posted
| 2019 | Year | 05 | Month | 25 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Now writing paper to publish
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
| 2012 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2012 | Year | 11 | Month | 26 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospectively registered
Management information
Registered date
| 2019 | Year | 05 | Month | 25 | Day |
Last modified on
| 2019 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041978
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