UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036004 |
|---|---|
| Receipt number | R000041009 |
| Scientific Title | Clinical research for NIRS-EEG-BMI rehabilitation for upper limb |
| Date of disclosure of the study information | 2019/02/25 |
| Last modified on | 2022/01/29 12:13:59 |
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Basic information
Public title
Clinical research for NIRS-EEG-BMI rehabilitation for upper limb
Acronym
NIRS-BMI
Scientific Title
Clinical research for NIRS-EEG-BMI rehabilitation for upper limb
Scientific Title:Acronym
NIRS-BMI
Region
| Japan |
Condition
Condition
hemiparesis patients due to stoke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the changes of function of brain, muscle and impairment of upper limbs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intracranial blood flow by near-infrared spectroscopy(NIRS) before and after intervention
Key secondary outcomes
electromyogram(EMG), electroencephalography(EEG), Fugl-Meyer Assessment (FMA) before and after intervention
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
During the training, the EEG-BMI device detect the EEG and evaluate Event-related Desyncronization (ERD), When the ERD of proper imagery detected, the device inform the proper imagery to the participants by orthosis movement and electric stimulation. This training encourage the motor learning of upper limbs.
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
impairment of upper limbs
Key exclusion criteria
sensory loss
cognitive impairment difficult to execute training
refractory epilepsy
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Daisuke Nishida |
Organization
Saiseikai Higashikanagawa Rehabilitation Hospital
Division name
Department of rehabilitation medicine
Zip code
Address
1-13-10 Nishikanagawa Kanagawa-ward Yokohama Kanagawa JAPAN
TEL
045-324-3600
prix0616@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Nishida |
Organization
Saiseikai Higashikanagawa Rehabilitation Hospital
Division name
Department of rehabilitation medicine
Zip code
Address
1-13-10 Nishikanagawa Kanagawa-ward Yokohama Kanagawa JAPAN
TEL
045-324-3600
Homepage URL
prix0616@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Japanese Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2019 | Year | 02 | Month | 25 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 02 | Month | 25 | Day |
Last modified on
| 2022 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041009
