The goal of this clinical study is to evaluate how accurately and safely the TES HT100 device can identify intracranial abnormalities in adult emergency department patients with mild head trauma or neurological symptoms that are not related to trauma and are not immediately life-threatening. The main questions it aims to answer are:
* How well does TES HT100 identify patients with intracranial abnormalities compared with head CT, the reference standard? * Is TES HT100 safe to use in this patient population? * Could TES HT100 help improve patient triage and use of hospital resources in the emergency setting?
Researchers will compare the result of TES HT100 with the head CT report.
Participants will:
* Be enrolled if they are adults presenting to the emergency department with mild head trauma or selected neurological symptoms * Undergo standard clinical assessment and head CT according to usual care * Have an additional TES HT100 examination lasting about 5 minutes, performed by trained personnel * Be assessed for device performance and any adverse events related to use of the device
Age greater than 18 years
Provision of informed consent
Presentation to the Emergency Department with mild head injury, or
syncope
Age less than 18 years
Pregnant women
Metal plates or metal prostheses installed in the skull cap
Severe head trauma and/or extensive lacerated-contused areas
Single group
Temnographic Brain Screening Examination
Diagnostic testA non-invasive, add-on diagnostic examination performed with the TES HT100 device to assess the presence or absence of intracranial abnormality in adult emergency department patients. The device uses ultra-low-power, non-ionizing electromagnetic waves in the 500-6500 MHz range and provides a binary on/off result. The examination lasts about 5 minutes, does not require direct contact with the patient's head, and is performed by trained personnel in addition to standard clinical evaluation and head CT.
Diagnostic accuracy of TES HT100 for detection of intracranial abnormalities
Diagnostic performance of TES HT100 compared with the head CT report as the reference standard, assessed by ROC-AUC and by sensitivity and specificity for identification of intracranial abnormalities.
Rate of device-related adverse events
Incidence and type of adverse events related to the use of TES HT100 during the study.
Operator time associated with TES HT100-supported screening
Descriptive evaluation of operator time associated with use of TES HT100 during emergency department screening, based on the number of TES HT100 examinations performed per participant and the approximate duration of each examination (about 5 minutes), as described in the protocol.
Procedures associated with TES HT100-supported screening
Descriptive evaluation of workflow-related procedures associated with use of TES HT100 during emergency department screening, as part of the exploratory assessment of potential clinical benefit described in the protocol. This may include patient handling or organizational procedures required during the diagnostic pathway, such as patient transfer to a different bed or room or need for additional staff support.
Costs associated with TES HT100-supported screening
Descriptive evaluation of resource use and related cost considerations associated with use of TES HT100 during emergency department screening, as part of the exploratory assessment of potential clinical benefit described in the protocol.
Diagnostic performance of TES HT100 in predefined patient subgroups
Analysis of TES HT100 diagnostic performance, based on sensitivity and specificity versus head CT, in predefined subgroups, including younger patients, older patients, patients with or without prior injury or brain surgery, and patients with or without neurodegenerative disease.
