UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000036848
Receipt No. 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 (Ver. 3)

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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
Last 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
Email tyamaguchi@yachts.ac.jp

Public contact
1st 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
Email tyamaguchi@yachts.ac.jp

Sponsor
Institute Tokyo Bay Rehabilitation Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041978