Intracranial Pressure IncreaseNCT05609071
Technology of Intracranial Pressure Estimation by Single-Channel EEG in Brain Disease
An observational study of Intracranial Pressure Increase and Brain Diseases, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
If intracranial pressure can be measured non-invasively using single-channel EEG, clinicians will be able to easily monitor changes in intracranial pressure in patients with brain diseases in the clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Pressure Increase, Brain Diseases
- How many people
- 10 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Mar 2022to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study is intended for patients admitted to the intensive care unit (ICU) who are adults (18 years or older) and who are undergoing intracranial pressure measurement for some type of brain disease. Except for cases where the 2-channel EEG cannot be attached, it is intended for patients who can acquire EEG.
Who may be able to join
- Age 18 years or older
- Patients have had or are planning to insert an intracranial pressure monitoring device due to brain diseases
- Emergency room or intensive care unit of the study hospital
Who cannot join
- EEG measurement is restricted due to trauma or head deformity
- The attachment of electrodes for EEG measurement interferes with the standard treatment
- Patients who do not agree to enroll to this study by patients or caregivers
Trial locations and contacts
1 site in 1 country.
About this study
If intracranial pressure can be measured non-invasively using single-channel EEG, clinicians will be able to easily monitor changes in intracranial pressure in patients with brain diseases in the clinical setting. Therefore, a more efficient treatment plan can be established and the prognosis of patients with brain disease can be expected to improve in the long term.
Read the detailed description
Study Objectives:
- Accuracy evaluation of single-channel EEG-based estimated intracranial pressure and actual intracranial pressure in patients with brain disease
- It is intended to improve the accuracy by analyzing and upgrading the correlation and concordance of the single-channel EEG-based estimated intracranial pressure compared with the actual intracranial pressure measurement of the patient.
Study design: Multi-center prospective clinical trial
The study procedure was explained to the caregiver of the patient with brain disease admitted to the emergency room or intensive care unit, who was or will be implanted with an intracranial pressure monitoring device and informed consent was obtained.
While the intracranial pressure monitoring device is being applied, EEG data and intracranial pressure data are simultaneously acquired by applying a single-channel EEG.
EEG-based intracranial pressure prediction model and actual intracranial pressure comparison analysis are conducted to evaluate the prediction model and upgrade it.
- Conditions
- Intracranial Pressure Increase, Brain Diseases
- Keywords
- Electroencephalogram, Intensive care unit, Intracranial pressure monitoring
- Medical subject headings
- Intracranial Hypertension, Brain Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between estimated intracranial pressure and actual intracranial pressure
The difference between the estimated intracranial pressure and the actual intracranial pressure is calculated using the previously developed intracranial pressure prediction formula using quantitative EEG parameters.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start22 Mar 2022
- Primary completion28 Feb 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial Pressure IncreaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ki Hong Kim, Study director, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05609071
- Sponsor's protocol ID
- SNUEMSBDICP
- Status last verified
- Apr 2023
- First submitted
- 30 Oct 2022
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology of Intracranial Pressure Estimation by Single-Channel EEG in Brain Disease
- ClinicalTrials.gov ID
- NCT05609071
- Acronym / sponsor ID
- SNUEMSBDICP
- Conditions
- Intracranial Pressure Increase, Brain Diseases
- Keywords
- Electroencephalogram, Intensive care unit, Intracranial pressure monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 22 Mar 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
If intracranial pressure can be measured non-invasively using single-channel EEG, clinicians will be able to easily monitor changes in intracranial pressure in patients with brain diseases in the clinical setting. Therefore, a more efficient treatment plan can be established and the prognosis of patients with brain disease can be expected to improve in the long term.
Detailed description
Study Objectives:
- Accuracy evaluation of single-channel EEG-based estimated intracranial pressure and actual intracranial pressure in patients with brain disease
- It is intended to improve the accuracy by analyzing and upgrading the correlation and concordance of the single-channel EEG-based estimated intracranial pressure compared with the actual intracranial pressure measurement of the patient.
Study design: Multi-center prospective clinical trial
The study procedure was explained to the caregiver of the patient with brain disease admitted to the emergency room or intensive care unit, who was or will be implanted with an intracranial pressure monitoring device and informed consent was obtained.
While the intracranial pressure monitoring device is being applied, EEG data and intracranial pressure data are simultaneously acquired by applying a single-channel EEG.
EEG-based intracranial pressure prediction model and actual intracranial pressure comparison analysis are conducted to evaluate the prediction model and upgrade it.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is intended for patients admitted to the intensive care unit (ICU) who are adults (18 years or older) and who are undergoing intracranial pressure measurement for some type of brain disease. Except for cases where the 2-channel EEG cannot be attached, it is intended for patients who can acquire EEG.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Patients have had or are planning to insert an intracranial pressure monitoring device due to brain diseases
- Emergency room or intensive care unit of the study hospital
Key exclusion criteria (3 listed)
- EEG measurement is restricted due to trauma or head deformity
- The attachment of electrodes for EEG measurement interferes with the standard treatment
- Patients who do not agree to enroll to this study by patients or caregivers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference between estimated intracranial pressure and actual intracranial pressure
Time frame: through study completion, an average of 1 year
The difference between the estimated intracranial pressure and the actual intracranial pressure is calculated using the previously developed intracranial pressure prediction formula using quantitative EEG parameters.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ki Hong Kim study director
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Pressure Increase and Brain Diseases, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference between estimated intracranial pressure and actual intracranial pressure (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2023.