UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034286 |
|---|---|
| Receipt number | 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 | 2023/03/30 18:46:33 |
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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
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
motohiko@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2018 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 31 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Terminated.
Management information
Registered date
| 2018 | Year | 09 | Month | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039087
