Clinical trial NCT05609071: Technology of Intracranial Pressure Estimation by Single-Channel EEG in Brain Disease
Official title: Technology of Intracranial Pressure Estimation by Single-Channel EEG in Brain Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Pressure Increase
Brain Diseases
Keywords: Electroencephalogram
Intensive care unit
Intracranial pressure monitoring
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-11-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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:

1. Accuracy evaluation of single-channel EEG-based estimated intracranial pressure and actual intracranial pressure in patients with brain disease
2. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Difference between estimated intracranial pressure and actual intracranial pressure
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University HOspital
Study officials:
affiliation: Seoul National University Hospital
name: Ki Hong Kim
role: STUDY_DIRECTOR
References: