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NCT06963775

Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials

Sponsor: Ramon Diaz-Arrastia

View on ClinicalTrials.gov

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

Official title: Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials (TMS-EEG)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

215

Start Date

2026-03-01

Completion Date

2030-07-31

Last Updated

2025-10-02

Healthy Volunteers

Yes

Conditions

Traumatic Brain Injury

Interventions

DEVICE

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

Delphi-MD utilizes the use of transcranial magnetic stimulation evoked electroencephalography (TMS-EEG) for diagnostic purposes in a wide range of neurological disorders. Delphi-MD includes a magnetic stimulator and coil, an EEG amplifier and electrode cap and software for the acquisition and analysis of the data. Delphi-MD stimulation protocol includes low intensities (sub motor thresholds) and frequencies over six stimulation sites (bilateral primary motor cortex, and bilateral dorsolateral prefrontal cortex).

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)

University of Pennsylvania

Philadelphia, Pennsylvania, United States