---
title: Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
nct_id: NCT06963775
overall_status: NOT_YET_RECRUITING
sponsor: Ramon Diaz-Arrastia
study_type: OBSERVATIONAL
primary_condition: Traumatic Brain Injury
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06963775.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06963775"
ct_last_update_post_date: 2025-10-02
last_seen_at: "2026-05-12T07:14:35.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials

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

**NCT ID:** [NCT06963775](https://clinicaltrials.gov/study/NCT06963775)

## Key Facts

- **Status:** NOT_YET_RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 215
- **Lead Sponsor:** Ramon Diaz-Arrastia
- **Collaborators:** QuantalX Neuroscience
- **Conditions:** Traumatic Brain Injury
- **Start Date:** 2026-03-01
- **Completion Date:** 2030-07-31
- **CT.gov Last Update:** 2025-10-02

## 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).

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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).
```

## Arms

- **Traumatic Brain Injury (Acute, Subacute, Chronic)**
- **Healthy Control**

## 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).

## Primary Outcomes

- **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)
- **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).

## Locations (1)

- University of Pennsylvania, Philadelphia, Pennsylvania, United States

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.university of pennsylvania|philadelphia|pennsylvania|united states` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT06963775*  
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