NCT06963775

Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 215 (estimated)
• Sponsor: Ramon Diaz-Arrastia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2026-03-01
• Primary completion: 2030-03-31
• Completion: 2030-07-31
• First posted: 2025-05-09
• Last updated: 2025-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study