Clinical Trials Directory

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UnknownNCT05609071

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

Status
Unknown
Phase
Study type
Observational
Enrollment
10 (estimated)
Sponsor
Seoul National University Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2022-03-22
Primary completion
2023-02-28
Completion
2024-12-31
First posted
2022-11-08
Last updated
2023-04-20

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT05609071. Inclusion in this directory is not an endorsement.