UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054569 |
|---|---|
| Receipt number | R000062309 |
| Scientific Title | Factors influencing clinicians' EEG interpretation: a randomized controlled trial |
| Date of disclosure of the study information | 2024/06/04 |
| Last modified on | 2024/07/10 19:46:46 |
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Basic information
Public title
Diagnostic accuracy of clinicians' EEG reading: a randomized controlled trial
Acronym
Diagnostic accuracy of clinicians' EEG reading: a randomized controlled trial
Scientific Title
Factors influencing clinicians' EEG interpretation: a randomized controlled trial
Scientific Title:Acronym
Factors influencing clinicians' EEG interpretation: a randomized controlled trial
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Our objective is to examine factors that influence EEG reading by clinicians in a randomized controlled trial.
Basic objectives2
Others
Basic objectives -Others
EEG reading
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of over-reading of epileptiform discharges
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Clinical information (Details not disclosed due to blinding of study participants)
Interventions/Control_2
Clinical information (Details not disclosed due to blinding of study participants)
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
| 24 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The candidate must be in or have completed a residency program in neurology, or pediatrics. Alternatively, they must have obtained either a neurologist or a pediatrician's board certification. In addition, they must have given their consent to participate in the study via the online form.
* Neurologists and pediatricians (each with a target number of 168 subjects) will be analyzed separately and independently.
Key exclusion criteria
Those who have never completed an EEG report in a clinical setting will be excluded. Those who cannot give consent for the study will be excluded. Those who have not obtained sufficient basic information other than the results of EEG decipherment will be excluded.
Target sample size
366
Research contact person
Name of lead principal investigator
| 1st name | Nobukazu |
| Middle name | |
| Last name | Nakasato |
Organization
Tohoku University Graduate School of Medicine
Division name
Epileptology
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
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 Graduate School of Medicine
Division name
Epileptology
Zip code
980-8575
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
022-717-7343
Homepage URL
nkst@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.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
| 2024 | Year | 06 | Month | 04 | 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 | 04 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 09 | Month | 01 | 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
Management information
Registered date
| 2024 | Year | 06 | Month | 04 | Day |
Last modified on
| 2024 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062309
