UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050574 |
|---|---|
| Receipt number | R000056878 |
| Scientific Title | Verification of intracranial internal carotid artery current |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/09/12 09:05:15 |
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Basic information
Public title
Verification of intracranial internal carotid artery current
Acronym
Verification of intracranial internal carotid artery current
Scientific Title
Verification of intracranial internal carotid artery current
Scientific Title:Acronym
Verification of intracranial internal carotid artery current
Region
| Japan |
Condition
Condition
epilepsy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesized that cardiac action potentials propagate to the brain via arteries. In this study, we will try to measure the current directly in the internal carotid artery in the skull.
Basic objectives2
Others
Basic objectives -Others
We will also attempt to measure the current and voltage flowing through exposed peripheral vessels (middle cerebral artery, anterior cerebral artery) other than the internal carotid artery, if any.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We attempt to identify currents from the heart in the intracranial internal carotid artery.
Key secondary outcomes
1. We attempt to measure the current and voltage flowing through the intracranial internal carotid artery.
2. We will also attempt to measure the current and voltage flowing through exposed peripheral vessels (middle cerebral artery, anterior cerebral artery) other than the internal carotid artery, if any.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
The subjects are patients who are scheduled to have surgery to expose the internal carotid artery by craniotomy. When the internal carotid artery is exposed during surgery, the surgeon applies the electrode used for the deep electrode to the internal carotid artery to measure the current. Measurements are taken three times and recorded. If the middle cerebral artery or anterior cerebral artery is exposed in addition to the internal carotid artery, the same procedure is used to measure the current and voltage flowing there.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Men and women over the age of 20
2. Patients undergoing surgery to expose the intracranial internal carotid artery
3. Patients who can consent in writing
Key exclusion criteria
1. Patients for whom surgery was discontinued
2. Patients whose surgery was changed
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakai |
Organization
Kochi Medical School Hospital
Division name
Neurosurgery
Zip code
783-8505
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan
TEL
+81888802397
enakai@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Eiichi |
| Middle name | |
| Last name | Nakai |
Organization
Kochi Medical School Hospital
Division name
Neurosurgery
Zip code
783-8505
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan
TEL
+81888802397
Homepage URL
enakai@kochi-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Eiichi Nakai
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board of Kochi Medical School
Address
Kohasu 185-1, Okocho, Nankoku, Kochi, Japan
Tel
+81888802180
is21@kochi-u.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
| 2023 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 01 | 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
| 2023 | Year | 03 | Month | 13 | Day |
Last modified on
| 2023 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056878
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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