Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials

Official title

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

Overview

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

• 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 p

Primary outcome measures

• 1. Differentiate between healthy controls and TBI participants in measured outputs of the DELPHI-MD device (WFA, STP, EPD, LPD, and Connectivity) [Time frame: Day 1]
• 2. Correlate DELPHI-MD outputs with neural deficits identified through patient reported and clinician reported outcome measures [Time frame: Day 1]

Eligibility criteria

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):

• 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.

Exclusion Criteria for Traumatic Brain Injury (Acute, Subacute, Chronic) group:

• 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
• Prisoners or patients in police custody
• Pregnancy
• 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:

• Age 18 years and older
• No history of TBI in the past 12 months

Exclusion Criteria for Healthy Control group:

• 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
• Prisoners or patients in police custody
• Pregnancy
• 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

United States · 1 center

• University of Pennsylvania — Philadelphia

Publications

• 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. PMID 33408607
• 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. PMID 34526957
• 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. PMID 31551761
• 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. PMID 39349492
• 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. PMID 39612660
• 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. PMID 34216938

Identifiers

NCT: NCT06963775 · 855370

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗