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| Name | Class |
|---|---|
| QuantalX Neuroscience | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traumatic Brain Injury (Acute, Subacute, Chronic) |
| ||
| Healthy Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel) | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 1. Differentiate between healthy controls and TBI participants in measured outputs of the DELPHI-MD device (WFA, STP, EPD, LPD, and Connectivity) |
| Day 1 |
| 2. Correlate DELPHI-MD outputs with neural deficits identified through patient reported and clinician reported outcome measures | For single timepoint (day 1). | Day 1 |
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Inclusion Criteria for Traumatic Brain Injury (Acute, Subacute, Chronic) group:
Age 18 years and older
Evidence of mechanical energy impacting the head or inertial forces affecting the head
Either (A) or (B):
Exclusion Criteria for Traumatic Brain Injury (Acute, Subacute, Chronic) group:
Inclusion Criteria for Healthy Control group:
Exclusion Criteria for Healthy Control group:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TBIRI Research | Contact | 267-271-4951 | tbiresearch@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33408607 | Background | Levy-Lamdan O, Zifman N, Sasson E, Efrati S, Hack DC, Tanne D, Dolev I, Fogel H. Evaluation of White Matter Integrity Utilizing the DELPHI (TMS-EEG) System. Front Neurosci. 2020 Dec 21;14:589107. doi: 10.3389/fnins.2020.589107. eCollection 2020. | |
| 34526957 | Background | Fogel H, Levy-Lamdan O, Zifman N, Hiller T, Efrati S, Suzin G, Hack DC, Dolev I, Tanne D. Brain Network Integrity Changes in Subjective Cognitive Decline: A Possible Physiological Biomarker of Dementia. Front Neurol. 2021 Aug 30;12:699014. doi: 10.3389/fneur.2021.699014. eCollection 2021. |
| Label | URL |
|---|---|
| Study device | View source |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D009422 | Nervous System Diseases |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| 31551761 | Background | Zifman N, Levy-Lamdan O, Suzin G, Efrati S, Tanne D, Fogel H, Dolev I. Introducing a Novel Approach for Evaluation and Monitoring of Brain Health Across Life Span Using Direct Non-invasive Brain Network Electrophysiology. Front Aging Neurosci. 2019 Sep 9;11:248. doi: 10.3389/fnagi.2019.00248. eCollection 2019. |
| 39349492 | Background | Zifman N, Levy-Lamdan O, Hiller T, Thaler A, Dolev I, Mirelman A, Fogel H, Hallett M, Maidan I. TMS-evoked potentials unveil occipital network involvement in patients diagnosed with Parkinson's disease within 5 years of inclusion. NPJ Parkinsons Dis. 2024 Sep 30;10(1):182. doi: 10.1038/s41531-024-00793-0. |
| 39612660 | Background | Lassman S, Zifman N, Fogel H, Hassin-Baer S, Anis S. TMS-evoked potentials provide novel neurophysiological features of Tourette syndrome. Parkinsonism Relat Disord. 2025 Jan;130:107217. doi: 10.1016/j.parkreldis.2024.107217. Epub 2024 Nov 22. |
| 34216938 | Background | Maidan I, Zifman N, Hausdorff JM, Giladi N, Levy-Lamdan O, Mirelman A. A multimodal approach using TMS and EEG reveals neurophysiological changes in Parkinson's disease. Parkinsonism Relat Disord. 2021 Aug;89:28-33. doi: 10.1016/j.parkreldis.2021.06.018. Epub 2021 Jun 29. |
| D020196 |
| Trauma, Nervous System |
| D014947 | Wounds and Injuries |