Study on Data Acquisition and Image Characteristics of Brain Multifrequency EIT in Healthy People and Patients With Brain Diseases

Healthy Clinical Trial

Official title:

Study on Data Acquisition and Image Characteristics of Brain Multifrequency EIT in Healthy People and Patients With Brain Diseases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05796349
• Other study ID #: AMCPLA
• Status: Completed
• Start date: June 1, 2022
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2023
• Source: Army Medical Center of PLA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to compare the differences in the features of cerebral multifrequency EIT(cMFEIT) images between healthy subjects and patients with brain diseases and to explore the possibility of applying multifrequency EIT to intracranial abnormality detection.16 healthy volunteers and 8 patients with brain diseases were recruited as experimental subjects, and the cerebral EIT data of 9 frequencies in the range of 21 kHz - 100 kHz of all subjects were acquired with an EH-300 MFEIT system.

Description:

For subjects who received clinical trials, 16 electrodes were placed equidistantly in their head, and brain EIT data were measured at 9 frequencies in the range of 21 kHz to 100 kHz by applying a current RMS of 176 microamps. The healthy group included 16 individuals (male, age 40.25±11.18). No history of brain disease and no abnormalities were seen on plain CT scans of their brains. Cerebral EIT data collection from healthy volunteers was performed in a dedicated laboratory with temperature controlled at 24±1 °C and 52%±1% humidity in 2022. The subjects were lying in a horizontal position. The patient group included 8 patients with brain diseases (7 males, age 59±10.46). Obvious lesions were visible on the patients' CT or MRI images, including 6 patients with intracranial hemorrhage, 1 patient with cerebral ischemia, and 1 patient with cerebral edema. Data from patients with brain diseases were collected at the neurosurgical intensive care unit at the Army Medical Center of PLA in 2022. The cerebral EIT data of the patients were collected in the same position as the healthy individuals. The MFEIT image sequence is obtained according to a certain imaging algorithm, and the ROI area ratio (AR_ROI) on the left and right sides of the image and the average value of the reconstructed ROI resistivity change (MVRRC_ROI) are extracted. Based on the extracted indicators, the geometric asymmetry index (GAI) and intensity asymmetry index (IAI) was further proposed to characterize the symmetry of MFEIT images, and the differences between the two groups of subjects on MFEIT images were statistically compared and analyzed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Health Group: No history of brain disease and no abnormalities were seen on plain CT scans of their brains.

2. Patient Group: Patients with cerebral hemorrhage, cerebral ischemia, and cerebral edema, less than 12 days after onset.

Exclusion Criteria:

1. Health Group:

• Neurological diseases such as epilepsy, brain tumors, and cerebral vascular malformations;
• Neurological symptoms such as headache and dizziness;
• Abnormal signals detected on CT.

2. Patient Group:

• With other brain diseases without cerebral hemorrhage, cerebral ischemia, or brain edema;
• With open craniocerebral injury;
• With severe agitation.

Related Conditions & MeSH terms

• Brain Diseases
• Brain Edema
• Brain Ischemia
• Cerebral Edema
• Cerebral Hemorrhage
• Cerebral Infarction
• Cerebral Ischemia
• Healthy
• Hemorrhage
• Ischemia

Intervention

Diagnostic Test:
• multifrequency EIT-based for detecting intracranial abnormalities
For subjects who received clinical trials, 16 electrodes were placed equidistantly in their head, and brain EIT data were measured at 9 frequencies in the range of 21 kHz to 100 kHz by applying a current RMS of 176 microamps.MFEIT image sequences were obtained according to certain imaging algorithms.

Locations

Country	Name	City	State
China	PLA Army Characteristic Medical Center	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Jieshi Ma

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Whether there is a significant difference in the characteristic indicators (such as symmetry indicators) of multifrequency EIT images between healthy individuals and patients with brain diseases.	When there are significant differences in these indicators (such as symmetry indicators) (p<0.05), there is no need for further data collection	Up to 12 days after the patient's onset