UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044846 |
|---|---|
| Receipt number | R000051221 |
| Scientific Title | Retrospective exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study) |
| Date of disclosure of the study information | 2021/07/13 |
| Last modified on | 2022/01/12 11:50:03 |
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Basic information
Public title
Retrospective exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Acronym
Retrospective exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Scientific Title
Retrospective exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Scientific Title:Acronym
Retrospective exploratory clinical study to identify epileptogenic foci by statistical analysis of electrocorticographic signals during general anesthesia in patients with intractable epilepsy (observational study)
Region
| Japan |
Condition
Condition
refractory epilepsy
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we analyze the effect of anesthetic agents on electroencephalography in refractory epilepsy patients equipped with chronic intracranial electrode. Our aim of this study is to examine whether it is possible to identify the epileptogenic foci of the patient using this method. Finally, it is expected that refractory epilepsy patients undergoing focal lobectomy can skip intracranial electrode placement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MI value at each anesthesia stage and each intracranial electrode.
The ECoG analysis period was divided into the following five anesthetic stages: [1] baseline wakefulness before the anesthetic induction; [2] first 1/3; [3] middle 1/3; [4] last 1/3 periods between the sevoflurane initiation and its concentration reaching 2.0 MAC; [5] sevoflurane 2.0 MAC maintenance.
Key secondary outcomes
MI value at given anesthesia stage and given intracranial electrode when the epileptigenic region and the non-epileptic region are classified
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
1) Patients with refractory epilepsy who are scheduled for focal resection after placement of intracranial electrode
2) Patients with obvious abnormalities in MRI in the area expected to show epileptogenicity
3) Patients with ASA-PS (American association of anesthesia physical status) 1-2
4) Patients in NCNP hospital
5) Patients achieving ILAE class 1 outcome at least six months after surgical resection
Key exclusion criteria
1) Patients who cannot be used sevoflurane
2) Patients who cannot be used propofol
3) The case an anesthetic other than sevoflurane, propofol, remifentanil, rocuronium is used during EEG measurement
4) Patients with ASA-PS3 or higher
5) Patients with epilepsy surgery not intended for radical surgery
6) The case does not agree with the prescribed bank consent
7) Other persons whom representative of this study consider inappropriate
8) Patients achieving ILAE class 2 or higher outcome at least six months after surgical resection
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Keiko |
| Middle name | |
| Last name | Wada |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Anesthesiology
Zip code
187-8551
Address
4-1-1, Ogawahigashi-cho, Kodaira-shi, Tokyo, Japan
TEL
042-341-2712
keikotoki@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Keiko |
| Middle name | |
| Last name | Wada |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Anesthesiology
Zip code
187-8551
Address
4-1-1, Ogawahigashi-cho, Kodaira-shi, Tokyo, Japan
TEL
042-341-2712
Homepage URL
keikotoki@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
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
National Center of Neurology and Psychiatry
Address
4-1-1, Ogawahigashi-cho, Kodaira-shi, Tokyo, Japan
Tel
042-341-2712
rinri-jimu@ncnp.go.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
| 2021 | Year | 07 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
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
Completed
Date of protocol fixation
| 2021 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 04 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 04 | Day |
Date trial data considered complete
| 2021 | Year | 11 | Month | 04 | Day |
Date analysis concluded
| 2021 | Year | 11 | Month | 04 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2021 | Year | 07 | Month | 13 | Day |
Last modified on
| 2022 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051221
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