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New treatment option for Mild Traumatic Brain Injury
Official title TES HT100 Clinical Validation for Brain Injury Screening in Patients With Mild Head Trauma or Neurological Symptoms
ClinicalTrials.gov ID: NCT07490418
What this study is testing
- What it's testing
- 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?
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Castel Volturno, CE, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Castel Volturno, CE, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.