[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590158":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":10,"centralContacts":22,"locations":28,"responsibleParty":46,"collaborators":50,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":62,"sex":63,"minAge":64,"maxAge":10,"enrollmentInfo":65,"targetDuration":10,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"University of Pennsylvania","OTHER",[8,13],{"label":9,"type":10,"description":10,"interventionNames":11},"Traumatic Brain Injury (Acute, Subacute, Chronic)",null,[12],"Device: Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel)",{"label":14,"type":10,"description":10,"interventionNames":15},"Healthy Control",[12],[17],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":10},"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.\n\nDelphi-MD stimulation protocol includes low intensities (sub motor thresholds) and frequencies over six stimulation sites (bilateral primary motor cortex, and bilateral dorsolateral prefrontal cortex).",[14,9],[23],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},"TBIRI Research","CONTACT","267-271-4951","tbiresearch@pennmedicine.upenn.edu",[29],{"facility":5,"status":10,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Philadelphia","Pennsylvania","19104","United States","US",{"type":36,"coordinates":37},"Point",[38,39],-75.16362,39.95238,{"lat":39,"lon":38},[42,43],{"name":24,"role":25,"phone":26,"phoneExt":10,"email":27},{"name":44,"role":45,"phone":10,"phoneExt":10,"email":10},"Ramon Diaz-Arrastia, MD, PhD","PRINCIPAL_INVESTIGATOR",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Ramon Diaz-Arrastia","Presidential Professor & Director of Clinical Traumatic Brain Injury Research Initiative, University of Pennsylvania Perelman School of Medicine",[51],{"name":52,"class":53},"QuantalX Neuroscience","INDUSTRY","100590158","assessment-of-traumatic-brain-injury-using-transcranial-magnetic-stimulated-evoked-potentials-100590158",false,"NCT06963775","Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials","Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials (TMS-EEG)","(TMS-EEG)","Inclusion Criteria for Traumatic Brain Injury (Acute, Subacute, Chronic) group:\n\n1. Age 18 years and older\n2. Evidence of mechanical energy impacting the head or inertial forces affecting the head\n3. Either (A) or (B):\n\n   1. Trauma-related abnormality on CT scan on admission\n   2. If CT normal, documented\u002Fverified TBI based on evidence of either loss of consciousness, post-traumatic amnesia, confusion, or post-traumatic symptoms.\n\nExclusion Criteria for Traumatic Brain Injury (Acute, Subacute, Chronic) group:\n\n1. 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)\n2. History of premorbid disabling condition that interfere with outcome assessments\n3. Bilaterally absent pupillary responses\n4. Penetrating traumatic brain injury\n5. Prisoners or patients in police custody\n6. Pregnancy\n7. Subjects with magnetic-sensitive devices implanted in their head or within 12 in. (30 cm) of the coil\u002Fprobe (examples: cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes\u002Fstimulators, aneurysm clips or coils, stents and bullet fragments).\n\nInclusion Criteria for Healthy Control group:\n\n1. Age 18 years and older\n2. No history of TBI in the past 12 months\n\nExclusion Criteria for Healthy Control group:\n\n1. 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)\n2. History of premorbid disabling condition that interfere with outcome assessments\n3. Prisoners or patients in police custody\n4. Pregnancy\n5. Subjects with magnetic-sensitive devices implanted in their head or within 12 in. (30 cm) of the coil\u002Fprobe (examples: cochlear implants, deep brain stimulators, vagus nerve stimulators, other implanted electrodes\u002Fstimulators, aneurysm clips or coils, stents and bullet fragments).",true,"ALL","18 Years",{"count":66,"type":67},215,"ESTIMATED","OBSERVATIONAL","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).",[71],"Traumatic Brain Injury",[73,71,74,75],"TBI","TMS-EEG","neurological disorders","NOT_YET_RECRUITING","2026-06-24",{"date":79,"type":80},"2026-06-25","ACTUAL",{"date":82,"type":67},"2026-07-15",{"date":84,"type":67},"2030-07-31",{"name":48,"class":6},1]