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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036852
Receipt No. 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 2019/05/27

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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
Email 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
Email tyamaguchi@yachts.ac.jp

Sponsor
Institute Yamagata Prefectural University of Health Sciences
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 Institutional review board of Yamagata Prefectural University of Health Sciences
Address 260 Kamiyanagi, Yamagata-shi, Yamagata, Japan
Tel 023-686-6611
Email 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
2021 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
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=R000041984

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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