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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002256
Receipt No. 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 2017/08/06

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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 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Hirata
Organization Osaka University
Division name Department of Neurosurgery, Medical School
Zip code
Address Yamadaoka, Suita
TEL 06-6879-3652
Email mhirata@nsurg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masayuki Hirata
Organization Osaka University
Division name Department of Neurosurgery, Medical School
Zip code
Address 2-2 Yamadaoka, Suita
TEL 06-6879-3652
Homepage URL
Email mhirata@nsurg.med.osaka-u.ac.jp

Sponsor
Institute Department of Neurosurgery, Osaka University Medical School
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Anticipated trial start date
2009 Year 05 Month 15 Day
Last follow-up date
2018 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
2017 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002762

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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