Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials

Launched by RAMON DIAZ-ARRASTIA · Apr 29, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a special brain test called transcranial magnetic stimulation (TMS) can help evaluate traumatic brain injury (TBI). The goal is to see how the brain responds to magnetic signals in patients who have experienced head injuries. If you're 18 years or older and have had a recent head injury or symptoms like confusion or loss of consciousness, you may be eligible to join the study. Healthy individuals without any recent head injuries can also participate as a control group.

If you decide to take part in the trial, you will undergo assessments using a device called the Delphi-MD, which sends magnetic pulses to your head to measure how your brain responds. It's important to note that certain factors, such as having a serious pre-existing neurological condition or being pregnant, may disqualify you from participation. This trial is not yet recruiting, so you would need to wait until it opens for enrollment. Overall, the trial aims to improve our understanding of brain injuries and how to assess them effectively.

Gender

ALL

Eligibility criteria

• Inclusion Criteria for Traumatic Brain Injury (Acute, Subacute, Chronic) group:
• • 1. Age 18 years and older
• • 2. Evidence of mechanical energy impacting the head or inertial forces affecting the head
• 3. Either (A) or (B):
• • 1. Trauma-related abnormality on CT scan on admission
• • 2. If CT normal, documented/verified TBI based on evidence of either loss of consciousness, post-traumatic amnesia, confusion, or post-traumatic symptoms.
• Exclusion Criteria for Traumatic Brain Injury (Acute, Subacute, Chronic) group:
• • 1. History of disabling pre-existing neurologic disease (Such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, or HIV-encephalitis)
• • 2. History of premorbid disabling condition that interfere with outcome assessments
• • 3. Bilaterally absent pupillary responses
• • 4. Penetrating traumatic brain injury
• • 5. Prisoners or patients in police custody
• • 6. Pregnancy
• • 7. Subjects with magnetic-sensitive devices implanted in their head or within 12 in. (30 cm) of the coil/probe (examples: cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments).
• Inclusion Criteria for Healthy Control group:
• • 1. Age 18 years and older
• • 2. No history of TBI in the past 12 months
• Exclusion Criteria for Healthy Control group:
• • 1. History of disabling pre-existing neurologic disease (Such as epilepsy, brain tumors, meningitis, cerebral palsy, encephalitis, brain abscesses, vascular malformations, cerebrovascular disease, Alzheimer's disease, multiple sclerosis, or HIV-encephalitis)
• • 2. History of premorbid disabling condition that interfere with outcome assessments
• • 3. Prisoners or patients in police custody
• • 4. Pregnancy
• • 5. Subjects with magnetic-sensitive devices implanted in their head or within 12 in. (30 cm) of the coil/probe (examples: cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes/stimulators, aneurysm clips or coils, stents and bullet fragments).