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).
Age 18 years and older
Evidence of mechanical energy impacting the head or inertial forces affecting the head
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.
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
We will enroll up to 145 patients with a traumatic brain injury diagnosis evaluated at University of Pennsylvania Health System over 5 years. We will also evaluate up to 70 uninjured healthy controls, matched by age and gender to TBI participants.
Cohort
Prospective
Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel)
DeviceDelphi-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).
1. Differentiate between healthy controls and TBI participants in measured outputs of the DELPHI-MD device (WFA, STP, EPD, LPD, and Connectivity)
1. WFA (Waveform Adherence) 2. STP (short-term plasticity) 3. EPD (Early Phase Deflection) 4. LPD (Late Phase Deflection) 5. Connectivity (these are all in arbitrary units)
2. Correlate DELPHI-MD outputs with neural deficits identified through patient reported and clinician reported outcome measures
For single timepoint (day 1).
Click on the lead sponsor to view all of their trials.
Ramon Diaz-Arrastia
Lead sponsor
University of Pennsylvania
Sponsor institution
QuantalX Neuroscience
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
