UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037906 |
|---|---|
| Receipt number | R000043206 |
| Scientific Title | Evaluation of bilateral trasfer changes by bilateral motor cortex network stimulation |
| Date of disclosure of the study information | 2019/09/03 |
| Last modified on | 2019/09/03 12:02:21 |
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Basic information
Public title
Evaluation of bilateral trasfer changes by bilateral motor cortex network stimulation
Acronym
Evaluation of bilateral trasfer changes by bilateral motor cortex network stimulation
Scientific Title
Evaluation of bilateral trasfer changes by bilateral motor cortex network stimulation
Scientific Title:Acronym
Evaluation of bilateral trasfer changes by bilateral motor cortex network stimulation
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using tACS, the functional connection between bilateral motor areas is changed, and changes in motor learning are examined.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor learning
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
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
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
transcranial alternating electrical stimulation (low frequency)
Interventions/Control_2
transcranial alternating electrical stimulation (high frequency)
Interventions/Control_3
sham stimulation
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy subject
Key exclusion criteria
Medical history of central nervous system disease
With pacemaker
With intracranial metal
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Naoyuki |
| Middle name | |
| Last name | Takeuchi |
Organization
Akita University
Division name
Pysical therapy
Zip code
010-8543
Address
Akita Hondo 1-1-1
TEL
0188846531
naoyuki@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Naoyuki |
| Middle name | |
| Last name | Takeuchi |
Organization
Akita University
Division name
Physical therapy
Zip code
010-8543
Address
Akita Hondo 1-1-1
TEL
0188846531
Homepage URL
naoyuki@med.hokudai.ac.jp
Sponsor or person
Institute
Akita University
Institute
Department
Personal name
Funding Source
Organization
Akita University
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
Akita University
Address
Akita Hondo 1-1-1
Tel
0188846531
naoyuki@med.hokudai.ac.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 03 | 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
| 2019 | Year | 07 | Month | 22 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 03 | Day |
Last modified on
| 2019 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043206
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
