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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034286
Receipt No. R000039087
Scientific Title Effect for spinal excitability under voluntary muscle contraction, motor imagery and transcranial direct current stimulation (tDCS). A pilot study using ulnar F-wave.
Date of disclosure of the study information 2018/12/01
Last modified on 2018/09/26

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Basic information
Public title Effect for spinal excitability under voluntary muscle contraction, motor imagery and transcranial direct current stimulation (tDCS). A pilot study using ulnar F-wave.
Acronym Effect of muscle contraction, motor imagery and tDCS for ulnar F wave. A pilot study.
Scientific Title Effect for spinal excitability under voluntary muscle contraction, motor imagery and transcranial direct current stimulation (tDCS). A pilot study using ulnar F-wave.
Scientific Title:Acronym Effect of muscle contraction, motor imagery and tDCS for ulnar F wave. A pilot study.
Region
Japan

Condition
Condition Normal adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To explore the changes of spinal excitability using ulnar F-wave under muscle contraction, motor imagery and after tDCS.
Basic objectives2 Others
Basic objectives -Others To explore the possibility of application to functional reconstruction from the viewpoint of rehabilitation medicine.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To compare F-wave amplitude,latency and persistence between baseline and muscle contraction, motor imagery and after tDCS.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Motor task(voluntary contraction and motor imagery: 3min.each) and tDCS (1mA, 20min.)
Interventions/Control_2
Interventions/Control_3
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 Not suffering Neurological diseases, and orthopedics diseases.
Not taking medication for any diseases or conditions.
Key exclusion criteria To exclude past history of bone fracture, neurological/psychiatric diseases.
To exclude someone taking medication for any diseases or conditions.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Motohiko Hara,MD,PhD
Organization Saitama Medical University
Division name Rehabilitation Medicine
Zip code
Address 38 Morohongo, Moroyama-machi, Saitama 350-0495, JAPAN
TEL 81-49-276-1255
Email motohiko@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Motohiko Hara
Organization Saitama Medical University
Division name Rehabilitation Medicine
Zip code
Address 38 Morohongo, Moroyama-machi, Saitama 350-0495, JAPAN
TEL 81-49-276-1255
Homepage URL
Email motohiko@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 埼玉医科大学病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2018 Year 10 Month 08 Day
Date of IRB
Anticipated trial start date
2018 Year 12 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 26 Day
Last modified on
2018 Year 09 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039087

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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