UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Difference of cortical activation pattern during motor execution and motor imagery assessed with simultaneour near-infrared spectroscopy(NIRS) and electroencephalography(EEG) in patients with stroke.
Title of the study (Brief title)	Difference of cortical activation pattern during motor execution and motor imagery assessed with simultaneour near-infrared spectroscopy(NIRS) and electroencephalography(EEG) in patients with stroke.
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the relationship among neural activity and cerebral blood flow in stroke patients during motor execution and motor imagery.
Basic objectives2	Others
Basic objectives -Others	To validate the effective neurorehabilitation for stroke.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Oxy-Hb concentration and the value of ERD in both hemisphere.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Participants were asked to extend all the fingers. During the task, NIRS-EEG data were simultaneously collected.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Participants with stroke inpatients in Tokyo Metropolitan Rehabilitation Hospital.
Key exclusion criteria	pacemaker or other implanted stimulator use, history of seizures, use of anticonvulsants, selective serotonin reuptake inhibitors, or benzodiaxepines, and other serious medical conditions.
Target sample size	30

Research contact person
Name of lead principal investigator	Mari Ito
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Address	35 Shinanomachi Shinjuku ku Tokyo
TEL	0353633833
Email	marippe419@yahoo.co.jp

Public contact
Name of contact person	Mari Ito
Organization	Kawasaki municipal hospital
Division name	Department of Rehabilitation
Address	12-1 Shinkawa tori Kawasaki ku Kawasaki city
TEL	0442335521
Homepage URL
Email	marippe419@yahoo.co.jp

Sponsor
Institute	Department of Rehabilitation Medicine, Keio University School of Medicine,
Institute
Department

Funding Source
Organization	the Ministry of Education, Culture, Sports, Science, and Technology, Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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 04 Month 14 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 10 Month 10 Day
Anticipated trial start date	2011 Year 11 Month 03 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 04 Month 14 Day
Last modified on	2017 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019877