UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Using the Movement-Related Cortical Potential to study Peripheral nerve electrical stimulation
Title of the study (Brief title)	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	sako atsuhiro
Organization	Aichi Prefecture Saiseikai Rehabilitation Hospital
Division name	Department of Rehabilitation
Address	Nagoya, Aichi Prefecture, Nishi-ku, Eisei 1-chome, 1-18
TEL	0525715251
Email	atsuhirosako@yahoo.co.jp

Public contact
Name of contact person	sako atsuhiro
Organization	Aichi Prefecture Saiseikai Rehabilitation Hospital
Division name	Department of Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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