UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020082
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email atsuhirosako@yahoo.co.jp

Sponsor
Institute Fujita Health University
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023202

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.