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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05609071
Other study ID # SNUEMSBDICP
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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