TES HT100 screening for intracranial problems after mild head injury or new neurological symptoms
TES HT100 Clinical Outcomes - Clinical Validation of the TES HT100 Temnograph for Brain Injury Screening in Patients With Mild Head Trauma or Suspected Neurological Symptoms (TESCO)
This test checks if the TES HT100 can quickly and safely find intracranial problems in adults who come to the emergency department with mild head injury or new non‑traumatic neurological symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 850 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | B&B srl Industry-sponsored |
| Locations | 1 site (Castel Volturno, CE) |
| Trial ID | NCT07490418 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, open‑label investigation in adult emergency department patients comparing a brief TES HT100 examination with routine head CT. The TES HT100 uses ultra‑low‑power electromagnetic waves (500–6500 MHz) to produce a binary result indicating presence or absence of intracranial abnormality, and the exam takes about five minutes. Trained staff perform the TES HT100 without access to the CT report, and radiologists reading the CT are blinded to TES results; CT reports serve as the reference standard. The device is tested as an add‑on to usual care and is not intended to replace clinical assessment or CT imaging.
Who should consider this trial
Good fit: Adults (age >18) who present to the emergency department with mild head injury or selected non‑traumatic neurological symptoms, are able to give informed consent, and do not have disqualifying skull implants or pregnancy are ideal candidates.
Not a fit: Children, pregnant women, patients in critical condition, those with visible skull fracture, severe head trauma, or metal plates/prostheses in the skull are excluded and are unlikely to benefit from this device.
Why it matters
Potential benefit: If successful, TES HT100 could provide a fast, non‑invasive way to help triage emergency patients and potentially reduce unnecessary CT scans.
How similar studies have performed: Comparable electromagnetic/temnographic approaches are relatively novel with only limited small studies suggesting promise but no definitive, widespread validation yet.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age greater than 18 years * Provision of informed consent * Presentation to the Emergency Department with mild head injury, or * Presentation to the Emergency Department for non-traumatic neurological symptoms and not in a critical condition, including: * syncope * spatial disorientation and/or loss of balance * speech disturbance and/or facial hemi-paresis * visual alterations * memory loss and/or confusional state Exclusion Criteria: * 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 * Critical condition * Visible skull fracture * Failure or inability to provide signed informed consent
Where this trial is running
Castel Volturno, CE
- Pineta Grande Hospital — Castel Volturno, Ce, Italy (Recruiting)
Study contacts
- Study coordinator: Fabrizio Alfieri
- Email: fabrizio.alfieri@temnography.com
- Phone: +39-081-19189806
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.