Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Ramon Diaz-Arrastia
Study ID
NCT06963775
Status
Enrolling By Invitation

Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

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).

Study Details

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).

Key Dates

First listed
May 9, 2025
Start date
Aug 24, 2026
Status verified
Aug 2026
Primary completion
Mar 31, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
215 participants (estimated)

Arms

  • Arm: Traumatic Brain Injury (Acute, Subacute, Chronic)
  • Arm: Healthy Control

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
University of Pennsylvania· Philadelphia, PA

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