UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022957 |
|---|---|
| Receipt number | R000023404 |
| Scientific Title | Detection of impaired neural circuits in central nervous system diseases and development of neurophysiological biomarkers for functional brain network abnormalities |
| Date of disclosure of the study information | 2016/06/30 |
| Last modified on | 2016/06/30 21:01:46 |
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Basic information
Public title
Detection of impaired neural circuits in central nervous system diseases and development of neurophysiological biomarkers for functional brain network abnormalities
Acronym
Detection of impaired neural circuits in central nervous system diseases
Scientific Title
Detection of impaired neural circuits in central nervous system diseases and development of neurophysiological biomarkers for functional brain network abnormalities
Scientific Title:Acronym
Detection of impaired neural circuits in central nervous system diseases
Region
| Japan |
Condition
Condition
cerebrovascular disease, Parkinson's syndrome, essential tremor and epilepsy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to detect impaired neural circuits and develop neurophysiological biomarkers for cerebrovascular disease, Parkinson's syndrome, essential tremor and epilepsy, analyzing MRI data and signals of magnetoencephalography and intracranial electrodes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
functional brain networks analyzed using MRI data and signals of magnetoencephalography and intracranial electrodes.
Key secondary outcomes
clinical assessment battery for each disease
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
idiopathic Parkinson's disease, essential tremor, acute stroke, normal control
Key exclusion criteria
none
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Haruhiko Kishima |
Organization
Osaka university graduate school of medicine
Division name
Department of neurosurgery
Zip code
Address
Yamadaoka 2-2, Suita, Osaka
TEL
06-6879-3652
hkishima@nsurg.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Haruhiko Kishima |
Organization
Osaka university graduate school of medicine
Division name
Department of neurosurgery
Zip code
Address
Yamadaoka 2-2, Suita, Osaka
TEL
06-6879-3652
Homepage URL
hkishima@nsurg.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka university
Institute
Department
Personal name
Funding Source
Organization
Japan agency for medical research and development
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
Address
Tel
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
大阪大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 17 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Estimating current sources from the brain magnetic field signals, and analyzing the power and functional connectivity for each frequency band.
Management information
Registered date
| 2016 | Year | 06 | Month | 30 | Day |
Last modified on
| 2016 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023404
