UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028235 |
|---|---|
| Receipt number | R000032317 |
| Scientific Title | Elucidation of the magnetic physiologic base about epilepsy activity development using an electroencephalogram and the magnetoencephalography |
| Date of disclosure of the study information | 2017/07/19 |
| Last modified on | 2023/01/18 09:38:30 |
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Basic information
Public title
Elucidation of the magnetic physiologic base about epilepsy activity development using an electroencephalogram and the magnetoencephalography
Acronym
Elucidation of the magnetic physiologic base about epilepsy activity development
Scientific Title
Elucidation of the magnetic physiologic base about epilepsy activity development using an electroencephalogram and the magnetoencephalography
Scientific Title:Acronym
Elucidation of the magnetic physiologic base about epilepsy activity development
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology | Surgery in general | Pediatrics |
| Psychiatry | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidate a developmental mechanism of the epilepsy activity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of a clinical symptom and the electroencephalogram, magnetoencephalographic signal source position
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 with drug-resistant intractable epilepsy
and paid healthy normal volunteers through open recruitment for comparison
Key exclusion criteria
1) Person with clear disturbance of consciousness
2) The person who puts on a pacemaker, implanted defibrillator
3) In the body a person (in a cerebral aneurysm clip, a bolt and a plate after fracture treatment, the orthodontic treatment of teeth after a hairdye for less than one month tattoos) with the metal
4) Person of a blind alley, nyctophobia
5) In addition, the person whom a research person in charge or a partaker judged to be inadequate as subjects
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Nobukazu |
| Middle name | |
| Last name | Nakasato |
Organization
Tohoku University
Division name
Dep. Epi
Zip code
9808575
Address
Seiryo-machi 2-1, Aoba-ku, Sendai, Miyagi
TEL
022-717-7343
nkst@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Nobukazu |
| Middle name | |
| Last name | Nakasato |
Organization
Tohoku University
Division name
Dep. Epi
Zip code
9808575
Address
Seiryo-machi 2-1, Aoba-ku, Sendai, Miyagi
TEL
022-717-7343
Homepage URL
nkst@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
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
the ethical committee of Tohoku University Graduate School of Medicine
Address
Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi
Tel
022-728-4105
rinri-2@proj.med.tohoku.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
| 2017 | Year | 07 | Month | 19 | 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
| 2017 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
non
Management information
Registered date
| 2017 | Year | 07 | Month | 14 | Day |
Last modified on
| 2023 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032317
