Traumatic Brain Injury
Conditions
Keywords
TBI, Traumatic Brain Injury, TMS-EEG, neurological disorders
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 magnetic stimulation (TMS), using the Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel).
Interventions
DEVICEDelphi-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).
Sponsors
Ramon Diaz-Arrastia
QuantalX Neuroscience
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Differentiate between healthy controls and TBI participants in measured outputs of the DELPHI-MD device (WFA, STP, EPD, LPD, and Connectivity) | Day 1 | 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 | Day 1 | For single timepoint (day 1). |
Countries
United States
Outcome results
None listed