UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007676 |
|---|---|
| Receipt number | R000009045 |
| Scientific Title | Clinical research on brain machine interfaces for motor and communication control |
| Date of disclosure of the study information | 2012/04/09 |
| Last modified on | 2022/02/04 15:07:57 |
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Basic information
Public title
Clinical research on brain machine interfaces for motor and communication control
Acronym
Clinical research on motor and communication BMIs
Scientific Title
Clinical research on brain machine interfaces for motor and communication control
Scientific Title:Acronym
Clinical research on motor and communication BMIs
Region
| Japan |
Condition
Condition
ALS, SMA
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate safety and efficacy of a wired BMI device for motor and communication control using temporarily placed brain surface grid electrodes in severe ALS or SMA patients. This contributes to chronic implantation of a fully-implantable wireless device.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
Safety of implantable devices
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Implantation of brain surface electrodes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) severe ALS or SMA
2) patients under artificial respiration control
3) older than 20years old
4) Informed consent is available from the patient himself by orally or verbally
Key exclusion criteria
1) severe brain lesion
2) severe functional abnormality by EEG or MEG
3) impassible to manipulate the device in the present study due to severe visualor auditory disturbance
4) severe disturbance in heart, lung, liver, kidney, cognitive function, or psychological function
5) malignancy
6) compromised patient
7) bleeding tendency
8) taking steroids or immunosuppressive agents
9) taking anticoagulant drugs
10) severe underlying diseases other than targer illness
11) inappropriate to participate
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | Toshiki |
| Middle name | |
| Last name | Yoshimine |
Organization
Osaka Univerisity Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3652
mhirata@nsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Hirata |
Organization
Osaka Univerisity Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita
TEL
06-6879-3652
Homepage URL
mhirata@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of neurosurgery, Osaka University Meidical Shchool
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Osaka University Hopital
Address
2-2 Yamadaoka, Suita-Shi, Osaka 565-0871, Japan
Tel
0662108289
soudan@dmi.med.osaka-u.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
| 2012 | Year | 04 | Month | 09 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/clinicalneurol/53/11/53_1405/_article/-char/ja/
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/clinicalneurol/53/11/53_1405/_article/-char/ja/
Number of participants that the trial has enrolled
1
Results
One patient participated in this study.
He underwent the placement of ECoG electrodes and we evaluated the safety and efficacy of motor and communication control of wired BM.
We obtained sufficient information from the patient.
Results date posted
| 2022 | Year | 02 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
ALS
Participant flow
IC-pre-registration-screening tests-IC-registration-electrode placement-evaluation-electrode removal
Adverse events
subdural hematoma
Outcome measures
robot hand control
communication control
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 10 | Month | 10 | Day |
Date of IRB
| 2012 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2012 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 06 | Day |
Last modified on
| 2022 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009045
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
