Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials

NCT06963775 | Not Yet Recruiting FDA Device

• 1 other identifier: 855370
• Study Type: observational
• Target: 215
• Locations: 1 country
• Sites: 1

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).

Conditions

Traumatic Brain Injury

Keywords

TBI; Traumatic Brain Injury; TMS-EEG; neurological disorders

Outcome Measures

Primary Outcomes (2)

• 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)

  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

Study Arms (2)

Traumatic Brain Injury (Acute, Subacute, Chronic)

Device: Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel)

Healthy Control

Device: Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel)

Interventions

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).

Healthy Control; Traumatic Brain Injury (Acute, Subacute, Chronic)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ramon Diaz-Arrastia: lead
• QuantalX Neuroscience: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (6)

• 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 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.

  PMID: 34526957 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.

  PMID: 31551761 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.

  PMID: 39349492 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.

  PMID: 39612660 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.

  PMID: 34216938 BACKGROUND

Related Links

• Study device

MeSH Terms

Conditions

Brain Injuries, Traumatic; Nervous System Diseases

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

TBIRI Research

CONTACT

267-271-4951; tbiresearch@pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Presidential Professor & Director of Clinical Traumatic Brain Injury Research Initiative, University of Pennsylvania Perelman School of Medicine

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: May 9, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 31, 2030
• Study Completion (Estimated): July 31, 2030
• Last Updated: October 2, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)