Reliability Evaluation of Temnography for Early Detection of Intracranial Lesions in Mild Traumatic Brain Injury Patient: A Preliminary Report of a New Portable, Non-Invasive Device.

Abstract

Mild Traumatic brain injury is classified based on Glasgow Coma Scale (GCS 13-15), it also involves transient alteration of brain function, which may lead to severe short- and long-term sequelae. When treating a patient with a mild head injury outside the hospital, it is of crucial importance to decide whether to transport him to a center without neurosurgery or to a center equipped with neurosurgery (primary centralization). Recent decades have seen exploration of portable, non-invasive devices for intracranial injury and stroke detection, with microwave frequency electromagnetic field technology showing promising clinical outcomes. This clinical investigation aims to assess the diagnostic accuracy of the TES HT100 medical device, utilizing electromagnetic fields for endocranial lesion screening. Patients with mild traumatic brain injury were randomly enrolled according to inclusion criteria. Twenty-three patients recruited from the Intensive Short-Term Observation (ISTO) unit at San Donato Hospital in Arezzo. The sensitivity and specificity of the TES HT were evaluated statistically against cranial computed tomography (CT), the gold standard. A preliminary analysis shows a sensitivity of 100% and a specificity of 100%. Based on these results, there is maximum concordance between the two examinations, and the AUC is 1. No adverse events related to the use of TES HT100 or the examination. The device's ability to differentiate patients with intracranial lesions from those without can streamline the diagnostic and therapeutic process, potentially leading to improved patient outcomes. If Temnography will maintain high standards of sensitivity and specificity with the expansion of the enrolled population, it could be considered as a stable screening tool in the Emergency Room (ER). We could think to apply this technology to reduce the length of stay that patients with mTBI have to spend in ER for observation. Temnography could also be useful in special categories of patients such as pregnant women or the pediatric population. Moreover, another front of future development of this technology could be extending the study to include Territorial Emergency. In this context, Temnography could aid centralized decision-making in patient care.