UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055401 |
|---|---|
| Receipt number | R000063296 |
| Scientific Title | Research on clinical application of BMI (Brain Machine Interface) technology using brain-derived potentials in hospitals |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/09/01 11:25:22 |
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Basic information
Public title
Research on clinical application of BMI (Brain Machine Interface) technology using brain-derived potentials in hospitals
Acronym
Research on clinical application of BMI (Brain Machine Interface) technology using brain-derived potentials in hospitals
Scientific Title
Research on clinical application of BMI (Brain Machine Interface) technology using brain-derived potentials in hospitals
Scientific Title:Acronym
Research on clinical application of BMI (Brain Machine Interface) technology using brain-derived potentials in hospitals
Region
| Japan |
Condition
Condition
Patients with motor impairment (including those diagnosed with a low level of consciousness) and cognitive impairment
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the feasibility of using the Neurocommunicator to detect scalp suprapotentials in actual hospital rooms for people with motor dysfunction, people with cognitive dysfunction, and normal subjects.
If it becomes possible in the future to communicate with persons with severe motor dysfunction by establishing the know-how for operating the device in hospital rooms through this study, it is expected not only to improve the quality of life of the patients and their families, but also to enable medical and nursing personnel to better understand their conditions when diagnosing/treating and caring for the patients with the causative disease. It is also expected to enable medical and care professionals to better understand the condition of the patient when diagnosing/treating and caring for the patient.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of techniques for measuring supra-scalp potentials (detection of brain-derived event-related potentials and rhythmic EEG, as well as blink-derived eye potentials)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients must be at least 16 years of age and able to observe changes in scalp surface potential (using the following measuring device, measurement time is about 30-60 minutes), and have motor or cognitive dysfunction or normal subjects who agree to participate in this study.
Key exclusion criteria
None
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Watanabe |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8576
Address
2-1-1, Amakubo, Tsukuba, IBARAKI
TEL
029-853-3220
shinya-watanabey@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Watanabe |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8576
Address
2-1-1, Amakubo, Tsukuba, IBARAKI
TEL
029-853-3220
Homepage URL
shinya-watanabey@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
AMED
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
University of Tsukuba
Address
2-1-1, Amakubo, Tsukuba, IBARAKI
Tel
029-853-3220
shinya-watanabey@md.tsukuba.ac.jp
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
| 2024 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study of EEG data
Management information
Registered date
| 2024 | Year | 09 | Month | 03 | Day |
Last modified on
| 2024 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063296
