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Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials

Enrolling By InvitationN/A

Sponsor: Ramon Diaz-Arrastia

Conditions: Traumatic Brain Injury

Interventions: Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel)

Countries: United States

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 magnetic stimulation (TMS), using the Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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).

Locations (1)

Philadelphia, Pennsylvania, United States