Technology of Intracranial Pressure Estimation by Single-Channel EEG in Brain Disease

Active, not recruiting

• Conditions: Intracranial Pressure Increase; Brain Diseases

• Registration Number: NCT05609071
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2022-03-22
• Study First Submitted: 2022-10-30
• Study First Submitted QC: 2022-11-06
• Study First Posted: 2022-11-08
• Primary Completion: 2023-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-20
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference between estimated intracranial pressure and actual intracranial pressure	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.

Trial Locations

Locations (1)

Seoul National University HOspital; 🇰🇷 Seoul, Korea, Republic of