UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044461 |
|---|---|
| Receipt number | R000050789 |
| Scientific Title | Development of Brain Machine Interface using deep brain electrode |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2022/06/14 17:46:29 |
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Basic information
Public title
Development of Brain Machine Interface using deep brain electrode
Acronym
Development of Brain Machine Interface using deep brain electrode
Scientific Title
Development of Brain Machine Interface using deep brain electrode
Scientific Title:Acronym
Development of Brain Machine Interface using deep brain electrode
Region
| Japan |
Condition
Condition
Movement disorders
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discrimination rates for motor type, emotion, and intention
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Parkinson's disease patients who have been or will be implanted with a implantable pulse generator capable of extracting local field potential
Sufficient motor and cognitive function to perform motor and cognitive tasks
Key exclusion criteria
Patients with declining cognitive function
Patients who have difficulty communicating
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Haruhiko |
| Middle name | |
| Last name | Kishima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
5650871
Address
2-2 Yamadaoka, Suita City, Osaka, Japan
TEL
+81-(6)-6879-3652
n-tani@nsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Tani |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
5650871
Address
2-2 Yamadaoka, Suita City, Osaka, Japan
TEL
+81-(6)-6879-3652
Homepage URL
n-tani@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Otemae Hospital
Osaka General Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2 Yamadaoka, Suita City, Osaka, Japan
Tel
+81-6-6210-8292
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
大阪大学大学院医学系研究科脳神経外科
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-randomized non-blinded prospective case series study
Management information
Registered date
| 2021 | Year | 06 | Month | 07 | Day |
Last modified on
| 2022 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050789
