UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058478 |
|---|---|
| Receipt number | R000066860 |
| Scientific Title | A systematic review (conducted as a scoping review) of clinical Indicators of nonconvulsive status epilepticus in the emergency department. |
| Date of disclosure of the study information | 2025/07/15 |
| Last modified on | 2025/07/15 16:57:02 |
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Basic information
Public title
A systematic review (conducted as a scoping review) of clinical Indicators of nonconvulsive status epilepticus in the emergency department.
Acronym
A systematic review (conducted as a scoping review) of clinical Indicators of nonconvulsive status epilepticus in the emergency department.
Scientific Title
A systematic review (conducted as a scoping review) of clinical Indicators of nonconvulsive status epilepticus in the emergency department.
Scientific Title:Acronym
A systematic review (conducted as a scoping review) of clinical Indicators of nonconvulsive status epilepticus in the emergency department.
Region
| Japan |
Condition
Condition
nonconvulsive status epilepticus
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical situations that should raise suspicion for nonconvulsive status epilepticus in adult patients presenting to the emergency department.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to identify and clarify the clinical signs and findings that should raise suspicion of nonconvulsive status epilepticus (NCSE) in adult patients presenting to the emergency department.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes are the types and characteristics of clinical signs and initial findings that suggest nonconvulsive status epilepticus (NCSE), along with their reported frequency and diagnostic context.
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
1) Studies involving adult patients (aged 18 years or older) presenting to the emergency department
2) Studies including cases or populations diagnosed with nonconvulsive status epilepticus (NCSE)
3) Studies describing clinical signs or findings related to the diagnostic process
4) Articles published in English or Japanese
5) Original research articles, including observational studies, case reports, case series, and diagnostic accuracy studies
Key exclusion criteria
1) Studies focusing exclusively on pediatric patients (under 18 years of age)
2) Studies that mention NCSE without specific description of clinical signs or findings
3) Secondary sources such as review articles, editorials, letters to the editor, and conference abstracts
4) Experimental or basic science studies not involving human clinical data
5) Articles written in languages other than English or Japanese
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Eisei |
| Middle name | |
| Last name | Hoshiyama |
Organization
Dokkyo Medical University
Division name
Department of Neurology and Emergency and Critical Care Center
Zip code
3210293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, Japan
TEL
0282861111
eisei@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Eisei |
| Middle name | |
| Last name | Hoshiyama |
Organization
Dokkyo Medical University
Division name
Department of Neurology and Emergency and Critical Care Center
Zip code
3210293
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, Japan
TEL
0282861111
Homepage URL
eisei@dokkyomed.ac.jp
Sponsor or person
Institute
Guideline committee of Japan Resuscitation Council (Neuroresuscitation)
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
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
Dokkyo Medical University
Address
880 Kitakobayashi, Mibu-machi, Shimotsuga-gun, Tochigi, Japan
Tel
0282861111
eisei@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
| 2025 | Year | 07 | Month | 15 | 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
| 2024 | Year | 06 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Database
We will use the PubMed, Cochrane Library databases, and ICHUSHI as database.
This study is a scoping review aimed at identifying clinical signs and findings that may suggest nonconvulsive status epilepticus (NCSE). No comparative interventions will be evaluated; the review will focus on descriptive information regarding clinical signs and initial findings.
Management information
Registered date
| 2025 | Year | 07 | Month | 15 | Day |
Last modified on
| 2025 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066860
