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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05609071
Collaborator
(none)
10
1
33.3
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Technology of Intracranial Pressure Estimation by Single-Channel EEG in Brain Disease
    Actual Study Start Date :
    Mar 22, 2022
    Anticipated Primary Completion Date :
    Feb 28, 2023
    Anticipated Study Completion Date :
    Dec 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University HOspital Seoul Korea, Republic of 03080

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Study Director: Ki Hong Kim, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT05609071
    Other Study ID Numbers:
    • SNUEMSBDICP
    First Posted:
    Nov 8, 2022
    Last Update Posted:
    Nov 8, 2022
    Last Verified:
    Mar 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Seoul National University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 8, 2022