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

June 24, 2026 updated by: Ramon Diaz-Arrastia

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

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

215

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
        • Principal Investigator:
          • Ramon Diaz-Arrastia, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

  1. Age 18 years and older
  2. Evidence of mechanical energy impacting the head or inertial forces affecting the head

  3. Either (A) or (B):

    1. Trauma-related abnormality on CT scan on admission
    2. 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:

  1. 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)
  2. History of premorbid disabling condition that interfere with outcome assessments
  3. Bilaterally absent pupillary responses
  4. Penetrating traumatic brain injury
  5. Prisoners or patients in police custody
  6. Pregnancy
  7. 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:

  1. Age 18 years and older
  2. No history of TBI in the past 12 months

Exclusion Criteria for Healthy Control group:

  1. 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)
  2. History of premorbid disabling condition that interfere with outcome assessments
  3. Prisoners or patients in police custody
  4. Pregnancy
  5. 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Control
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 prefrontal cortex).
Traumatic Brain Injury (Acute, Subacute, Chronic)
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 prefrontal cortex).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
Time Frame: Day 1
  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
Time Frame: Day 1
For single timepoint (day 1).
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramon Diaz-Arrastia

Collaborators

QuantalX Neuroscience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 15, 2026

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

April 29, 2025

First Posted (Actual)

May 9, 2025

Study Record Updates

Last Update Posted (Actual)

June 25, 2026

Last Update Submitted That Met QC Criteria

June 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 855370

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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