An observational study in Cerebral Hemorrhage, Cerebral Ischemia and Cerebral Edema, sponsored by Jieshi Ma. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2023-04-03.
Sponsored by Jieshi Ma · Observational
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.
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.
457 studies on the registry are indexed under Cerebral Hemorrhage; 172 are open to participants now.
This study's enrollment of 24 is below the median of 300 across 180 observational studies indexed under Cerebral Hemorrhage.
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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.
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Exclusion Criteria:
Health Group:
Patient 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
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
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.
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
Time frame: Up to 12 days after the patient's onset
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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