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

NCT05796349 | Completed

• 1 other identifier: AMCPLA
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Hemorrhage; Cerebral Ischemia; Cerebral Edema; Healthy

Keywords

Multifrequency electrical impedance tomography; Intracranial abnormality; Detection; Symmetry

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

healthy group

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.

Diagnostic Test: multifrequency EIT-based for detecting intracranial abnormalities

patient group

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

Diagnostic Test: multifrequency EIT-based for detecting intracranial abnormalities

Interventions

multifrequency EIT-based for detecting intracranial abnormalities DIAGNOSTIC_TEST

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.

healthy group; patient group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Health Group: No history of brain disease and no abnormalities were seen on plain CT scans of their brains. Patient Group: Obvious lesions were visible on the patient's CT or MRI images.

You may qualify if:

• Health Group: No history of brain disease and no abnormalities were seen on plain CT scans of their brains.
• Patient Group: Patients with cerebral hemorrhage, cerebral ischemia, and cerebral edema, less than 12 days after onset.

You may not qualify if:

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

Sponsors & Collaborators

• Jieshi Ma: lead

Study Sites (1)

PLA Army Characteristic Medical Center

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Brain Ischemia; Brain Edema

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Director of MedicaEngineering Department

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: June 1, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: April 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)