UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002121 |
|---|---|
| Receipt number | R000002586 |
| Scientific Title | Development of non-invasive brain-machine interface and its application to the rehabilitation medicine |
| Date of disclosure of the study information | 2009/06/29 |
| Last modified on | 2015/10/31 10:54:24 |
* 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
Development of non-invasive brain-machine interface and its application to the rehabilitation medicine
Acronym
Development of brain-machine interface and its application to the rehabilitation medicine
Scientific Title
Development of non-invasive brain-machine interface and its application to the rehabilitation medicine
Scientific Title:Acronym
Development of brain-machine interface and its application to the rehabilitation medicine
Region
| Japan |
Condition
Condition
Stroke, spinal cord injury, neuromuscular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We devised a Brain-Macine Interface (BMI) with surface electroencepharogram (EEG) to analyze the intension to move the limb. The aim of this study is to assess its effects on motor cortex and therapeutic effect for patients with disabilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
EEG
Transcranial magnetic stimulation
Stroke Impairment Assessment Set
Key secondary outcomes
NIRS
Modified Ashworth scale
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 | Maneuver |
Interventions/Control_1
Upper extremity training with using BMI
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with motor impairment
Score of MMSE over 24
Patients showed no sign of visuospatial neglect
Patients attend this experiment at least for 3 months
Key exclusion criteria
Medical history of seizure or the other medical complication which inhibit to recruit this experiment.
Patients implanted pacemaker
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Fujiwara |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-5363-3833
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiyuki Fujiwara |
Organization
Keio University School of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo
TEL
03-5363-3833
Homepage URL
tofuji@xc5.so-net.ne.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Strategic Research Program for Brain Science from the Ministry of Education, Culture, Sports, Science and Technology Japan
Organization
Division
Category of Funding Organization
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
| 2009 | Year | 06 | Month | 29 | 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
| 2009 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 25 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 25 | Day |
Last modified on
| 2015 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002586
