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

NCT05609071 | Unknown DMC

• 1 other identifier: SNUEMSBDICP
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracranial Pressure Increase; Brain Diseases

Keywords

Electroencephalogram; Intensive care unit; Intracranial pressure monitoring

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University HOspital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Intracranial Hypertension; Brain Diseases

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Ki Hong Kim

  Seoul National University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 8, 2022
• Study Start: March 22, 2022
• Primary Completion: February 28, 2023
• Study Completion: December 31, 2024
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

KR (1)