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

Brain Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05609071
• Other study ID #: SNUEMSBDICP
• Status: Active, not recruiting
• Start date: March 22, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: December 31, 2024
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Intracranial Hypertension
• Intracranial Pressure Increase

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University HOspital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year