UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050996 |
|---|---|
| Receipt number | R000058134 |
| Scientific Title | Elucidation of pathomechanisms of delirium by EEG analysis: a cross-sectional study |
| Date of disclosure of the study information | 2023/08/31 |
| Last modified on | 2023/10/10 15:45:03 |
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Basic information
Public title
Elucidation of pathomechanisms of delirium by EEG analysis: a cross-sectional study
Acronym
Epileptic EEG activity in delirium
Scientific Title
Elucidation of pathomechanisms of delirium by EEG analysis: a cross-sectional study
Scientific Title:Acronym
Epileptic EEG activity in delirium
Region
| Japan |
Condition
Condition
delirium
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hypothesis to be tested: Might part of delirium involve paroxysms of the temporal lobe as a pathomechanism?
Basic objectives2
Others
Basic objectives -Others
Exploration of pathomechanisms
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of paroxysms (interictal period) on EEG in patients with delirium
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with delirium as defined by the DSM-5
Key exclusion criteria
Patients other than delirium
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Hatta |
Organization
Juntendo University Nerima Hospital
Division name
Department of Psychiatry
Zip code
177-8521
Address
3-1-10 Takanodai, Nerima-ku, Tokyo
TEL
+81-3-5923-3111
khatta@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Hatta |
Organization
Juntendo University Nerima Hospital
Division name
Department of Psychiatry
Zip code
177-8521
Address
3-1-10 Takanodai, Nerima-ku, Tokyo
TEL
+81-3-5923-3111
Homepage URL
khatta@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Kotaro Hatta
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS KAKENHI)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Nippon Medical School Musashikosugi Hospital, Tokyo Medical and Dental University, Hiroshima City Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Institutional Review Board
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
Tel
03-3814-5672
jcrtc_operation@juntendo.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
順天堂大学練馬病院（東京都）、東京医科歯科大学病院（東京都）、日本医科大学武蔵小杉病院（神奈川県）、広島市民病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 31 | 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
| 2023 | Year | 05 | Month | 09 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) Basic information on study subjects: age, gender, height, weight, major illnesses, alcohol and drug history, medications, Charlson comorbidity index, APACHE II score, ECOG Performance Status score, Clinical Dementia Rating (CDR) score
(2)Observation of delirium: The presence or absence of delirium as defined in DSM-5 will be assessed daily for 7 days. The Delirium Rating Scale-Revised (DRS-R-98) and the Delirium Etiology Rating Checklist will be assessed at the time of enrollment and at the time of reappearance of delirium. The active form of delirium will be recorded at the same time.
(3) Electroencephalography: The electroencephalography will be performed on the day of enrollment. Electrode placement will be noninvasive, with T1 and T2 added to the usual 10-20 method, which can detect the medial temporal lobe as a focus for temporal lobe epilepsy, which frequently occurs in the elderly. The standard reference electrode guidance (earlobe electrode), bipolar guidance, and AV methods are used for derivation. For waveforms that are difficult to determine with these derivation methods, derivation using the temporal region on the opposite side of the spine wave as a reference is used (noninvasive). The standard recording time is 30 minutes, and if the patient does not transition to a sleep EEG, the patient should wait until about 1 hour, if possible, before transitioning to sleep. Record whether the patient has transitioned to sleep.
Management information
Registered date
| 2023 | Year | 05 | Month | 07 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058134
