Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06963775

Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location contact

Ramon Diaz-Arrastia, MD, PhD

PRINCIPAL_INVESTIGATOR

TBIRI Research

CONTACT

[email protected]

267-271-4951

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

Primary outcomes

  1. 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

    • WFA (Waveform Adherence)
    • STP (short-term plasticity)
    • EPD (Early Phase Deflection)
    • LPD (Late Phase Deflection)
    • Connectivity (these are all in arbitrary units)
  2. 2. Correlate DELPHI-MD outputs with neural deficits identified through patient reported and clinician reported outcome measures

    Time frame: Day 1

    For single timepoint (day 1).

Study contacts

Contact information is provided by the study sponsor or research team.

TBIRI Research

CONTACT

[email protected]

267-271-4951

Sponsors and collaborators

Lead sponsor

Ramon Diaz-Arrastia

Other

Collaborators

  • QuantalX Neuroscience

Registry information

Official study title

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

Acronym: (TMS-EEG)

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 9, 2025
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.