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

April 19, 2023 updated by: Seoul National University Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference between estimated intracranial pressure and actual intracranial pressure
Time Frame: 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.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

October 30, 2022

First Submitted That Met QC Criteria

November 6, 2022

First Posted (Actual)

November 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2023

Last Update Submitted That Met QC Criteria

April 19, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SNUEMSBDICP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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