UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020082 |
|---|---|
| Receipt number | R000023202 |
| Scientific Title | Using the Movement-Related Cortical Potential to study Peripheral nerve electrical stimulation |
| Date of disclosure of the study information | 2015/12/10 |
| Last modified on | 2017/04/24 11:11:02 |
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Basic information
Public title
Using the Movement-Related Cortical Potential to study Peripheral nerve electrical stimulation
Acronym
Usin the Movement-Related Cortical Potential to study Peripheral nerve electrical stimulation
Scientific Title
Using the Movement-Related Cortical Potential to study Peripheral nerve electrical stimulation
Scientific Title:Acronym
Usin the Movement-Related Cortical Potential to study Peripheral nerve electrical stimulation
Region
| Japan |
Condition
Condition
Healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to enforce the Perpherial nerve stimulation to the radial nerve, we examined the impact of the movement-related cortical areas by actually evaluating the MRCP at the time of the wrist joint dorsiflexion movement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Movement related cortical potential
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Treatment A: peripheral nerve electrical stimulation (stimulation time: 45 minutes (including 15 minutes active movement combination), stimulation intensity: 10mA, frequency: 10Hz, pulse interval: 0.25ms, On / Off 500-1000ms / 500-1000ms)
Treatment B: fake stimulus and active movement (false stimulation (electrode installation only): 45 minutes, automatic movement 15 minutes)
order
Treatment A - rest period (3 days or more) - treatment B
Interventions/Control_2
Treatment A: peripheral nerve electrical stimulation (stimulation time: 45 minutes (including 15 minutes active movement combination), stimulation intensity: 10mA, frequency: 10Hz, pulse interval: 0.25ms, On / Off 500-1000ms / 500-1000ms)
Treatment B: fake stimulus and active movement (false stimulation (electrode installation only): 45 minutes, automatic movement 15 minutes)
order
Treatment B - rest period (3 days or more) - treatment A
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
| 21 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Has a normal (including corrected visual acuity) vision and hearing, nervous system disease, orthopedic disease, disorder with no healthy adults in cardiopulmonary function.
Key exclusion criteria
Who Movemnet-related cortical potential could not be measured
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | sako atsuhiro |
Organization
Aichi Prefecture Saiseikai Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
Address
Nagoya, Aichi Prefecture, Nishi-ku, Eisei 1-chome, 1-18
TEL
0525715251
atsuhirosako@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | sako atsuhiro |
Organization
Aichi Prefecture Saiseikai Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
Address
Nagoya, Aichi Prefecture, Nishi-ku, Eisei 1-chome, 1-18
TEL
0525715251
Homepage URL
atsuhirosako@yahoo.co.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 02 | 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
| 2015 | Year | 12 | Month | 05 | Day |
Last modified on
| 2017 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023202
