UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036852 |
|---|---|
| Receipt number | R000041984 |
| Scientific Title | The effect of non-invasive electrical stimulation for brain and peripheral nerves on motor performance and neural function |
| Date of disclosure of the study information | 2019/05/25 |
| Last modified on | 2021/07/06 15:47:54 |
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Basic information
Public title
The effect of non-invasive electrical stimulation for brain and peripheral nerves on motor performance and neural function
Acronym
Non-invasive electrical stimulation of the brain and peripheral nerves
Scientific Title
The effect of non-invasive electrical stimulation for brain and peripheral nerves on motor performance and neural function
Scientific Title:Acronym
Non-invasive electrical stimulation of the brain and peripheral nerves
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study is to investigate whether non-invasive electrical stimulation could improve the motor performance and enhance the neural function in healthy individuals
Basic objectives2
Others
Basic objectives -Others
Basic science research for clinical application
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Motor evoked potential
Key secondary outcomes
Electroencephalography, Evoked electromyogram, Electromyography, Muscle strength, Pulmonary function test,Balance, Motion analysis
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
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Non-invasive electrical stimulation(single session)
Interventions/Control_2
Sham non-invasive electrical stimulation(single session)
Interventions/Control_3
Control condition(single session)
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
| 18 | 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
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
200
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
990-2212
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
Yamagata Prefectural University of Health Sciences
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
Institutional review board of Yamagata Prefectural University of Health Sciences
Address
260 Kamiyanagi, Yamagata-shi, Yamagata, Japan
Tel
023-686-6611
kyogaku@yachts.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
1905-05
Org. issuing International ID_1
Yamagata Prefectural University of Health Sciences
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
山形県立保健医療大学（山形県）
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
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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | 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 | 05 | Month | 25 | Day |
Last modified on
| 2021 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041984
| 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 |
