Status:
NOT_YET_RECRUITING
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Lead Sponsor:
Ramon Diaz-Arrastia
Collaborating Sponsors:
QuantalX Neuroscience
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18+ years
Brief Summary
Patients evaluated at Penn Presbyterian Medical Center for traumatic brain injury (TBI), who sign the informed consent, will undergo assessment of electrophysiologic potentials evoked by transcranial ...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Traumatic Brain Injury (Acute, Subacute, Chronic) group:
- Age 18 years and older
- Evidence of mechanical energy impacting the head or inertial forces affecting the head
- Either (A) or (B):
- Trauma-related abnormality on CT scan on admission
- 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:
- 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)
- History of premorbid disabling condition that interfere with outcome assessments
- Bilaterally absent pupillary responses
- Penetrating traumatic brain injury
- Prisoners or patients in police custody
- Pregnancy
- 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:
- Age 18 years and older
- No history of TBI in the past 12 months
- Exclusion Criteria for Healthy Control group:
- 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)
- History of premorbid disabling condition that interfere with outcome assessments
- Prisoners or patients in police custody
- Pregnancy
- 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).
Exclusion
Key Trial Info
Start Date :
March 1 2026
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2030
Estimated Enrollment :
215 Patients enrolled
Trial Details
Trial ID
NCT06963775
Start Date
March 1 2026
End Date
July 31 2030
Last Update
October 2 2025
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104