UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017139 |
|---|---|
| Receipt number | R000019877 |
| Scientific 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. |
| Date of disclosure of the study information | 2015/04/14 |
| Last modified on | 2017/09/27 15:47:28 |
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Basic information
Public 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.
Acronym
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.
Scientific 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.
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Mari Ito |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi Shinjuku ku Tokyo
TEL
0353633833
marippe419@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari Ito |
Organization
Kawasaki municipal hospital
Division name
Department of Rehabilitation
Zip code
Address
12-1 Shinkawa tori Kawasaki ku Kawasaki city
TEL
0442335521
Homepage URL
marippe419@yahoo.co.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, Keio University School of Medicine,
Institute
Department
Personal name
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)
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 | 04 | Month | 14 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 10 | Month | 10 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019877
