UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050469 |
|---|---|
| Receipt number | R000057484 |
| Scientific Title | Single arm observational study on the development of methods for analyzing epileptic electroencephalograms |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/03/02 10:10:20 |
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Basic information
Public title
Neural mechanism of epileptic EEG signals using time-frequency dynamic analysis
Acronym
Neural mechanism of epileptic EEG signals using time-frequency dynamic analysis
Scientific Title
Single arm observational study on the development of methods for analyzing epileptic electroencephalograms
Scientific Title:Acronym
Single arm observational study on the development of methods for analyzing epileptic electroencephalograms
Region
| Japan |
Condition
Condition
epilepsy
Classification by specialty
| Neurosurgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate an analytical method to extract the spatio-temporal dynamics of brain activity before, during and after an epileptic seizure by applying dynamic modal decomposition analysis to the cortical EEG of epileptic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The predictive accuracy of the indicators for predicting the occurrence of epileptic seizures will be evaluated.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients treated for epilepsy at the Department of Neurosurgery, Dokkyo Medical University Hospital who have undergone cortical electroencephalography
Key exclusion criteria
None
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Toshimitsu |
| Middle name | |
| Last name | Takahashi |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Physiology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-86-2126
tositaka@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Toshimitsu |
| Middle name | |
| Last name | Takahashi |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Physiology
Zip code
0282-86-2126
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
0282-86-2126
Homepage URL
tositaka@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board for Clinical Research
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
Tel
0282-87-2275
r-kenkyu@dokkyomed.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
| 2023 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2033 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We analyze in detail how the spatiotemporal dynamics of brain activity changes during epileptogenesis by dynamic mode decomposition analysis. Specifically, we analyze the stability and spatial distribution of the obtained dynamic modes to understand the mechanism of local oscillation generation and its spatial propagation.
Management information
Registered date
| 2023 | Year | 03 | Month | 02 | Day |
Last modified on
| 2023 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057484
