UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002256 |
|---|---|
| Receipt number | R000002762 |
| Scientific Title | Development of functional prosthesis based on the neural decoding using intracranial electrodes |
| Date of disclosure of the study information | 2009/07/27 |
| Last modified on | 2022/02/04 14:01:08 |
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Basic information
Public title
Development of functional prosthesis based on the neural decoding using intracranial electrodes
Acronym
Functional prosthesis using intracranial electrodes
Scientific Title
Development of functional prosthesis based on the neural decoding using intracranial electrodes
Scientific Title:Acronym
Functional prosthesis using intracranial electrodes
Region
| Japan |
Condition
Condition
1)intractable epilepsy, 2)intractable pain, 3)brain tumor, 4)movement disorder
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop real time BCI based on the neural decoding using intracranial electrodes.
To develop a new prosthetic approach by combining electrocal stimulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
decoding accuracy
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 | Maneuver |
Interventions/Control_1
recording brain signals from intracaranial 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
| 10 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
intracranial electrode:
1)intractable epilepsy
2)intractable pain
3)brain tumor
depth electrodes:
4)movement disorder
Key exclusion criteria
Safety of electrical stimulation is confirmed in case electrical stimulationis performed
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Hirata |
Organization
Osaka University
Division name
Department of Neurosurgery, Medical School
Zip code
565-0871
Address
Yamadaoka, Suita
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 University
Division name
Department of Neurosurgery, Medical School
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 Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Address
Yamadaoka2-2, Suita, Osaka, Japan
Tel
0662108429
rinri@hp-crc.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
| 2009 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2009 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2024 | 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
| 2009 | Year | 07 | Month | 27 | 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=R000002762
