Traumatic Brain Injury(TMS-EEG)NCT06963775
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
An observational study of Traumatic Brain Injury, run by Ramon Diaz-Arrastia at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel)
- Type of treatment
- Medical device
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2026to 31 Jul 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 18 years and older
- No history of TBI in the past 12 months
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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).
- Conditions
- Traumatic Brain Injury
- Being tested
- Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel)
- Keywords
- TBI, Traumatic Brain Injury, TMS-EEG, neurological disorders
- Medical subject headings
- Brain Injuries, Traumatic, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Traumatic Brain Injury (Acute, Subacute, Chronic) | Not described Receives: Device: Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel) | |
| Healthy Control | Not described Receives: Device: Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Differentiate between healthy controls and TBI participants in measured outputs of the DELPHI-MD device (WFA, STP, EPD, LPD, and Connectivity)
- WFA (Waveform Adherence)
- STP (short-term plasticity)
- EPD (Early Phase Deflection)
- LPD (Late Phase Deflection)
- Connectivity (these are all in arbitrary units)
Measured: Day 1
2. Correlate DELPHI-MD outputs with neural deficits identified through patient reported and clinician reported outcome measures
For single timepoint (day 1).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2025
- Study start3 Sep 2026
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramon Diaz-Arrastia
- Sponsor type
- University, hospital or other
- Collaborators
- QuantalX Neuroscience
- Responsible party
- Sponsor-investigator, Ramon Diaz-Arrastia, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963775
- Sponsor's protocol ID
- 855370
- Acronym
- (TMS-EEG)
- Status last verified
- Oct 2026
- First submitted
- 7 Mar 2025
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Levy-Lamdan O, Zifman N, Sasson E, Efrati S, Hack DC, Tanne D, Dolev I, Fogel H. Evaluation of White Matter Integrity Utilizing the DELPHI (TMS-EEG) System. Front Neurosci. 2020 Dec 21;14:589107. doi: 10.3389/fnins.2020.589107. eCollection 2020.
PubMed 33408607Fogel H, Levy-Lamdan O, Zifman N, Hiller T, Efrati S, Suzin G, Hack DC, Dolev I, Tanne D. Brain Network Integrity Changes in Subjective Cognitive Decline: A Possible Physiological Biomarker of Dementia. Front Neurol. 2021 Aug 30;12:699014. doi: 10.3389/fneur.2021.699014. eCollection 2021.
PubMed 34526957Zifman N, Levy-Lamdan O, Suzin G, Efrati S, Tanne D, Fogel H, Dolev I. Introducing a Novel Approach for Evaluation and Monitoring of Brain Health Across Life Span Using Direct Non-invasive Brain Network Electrophysiology. Front Aging Neurosci. 2019 Sep 9;11:248. doi: 10.3389/fnagi.2019.00248. eCollection 2019.
PubMed 31551761Zifman N, Levy-Lamdan O, Hiller T, Thaler A, Dolev I, Mirelman A, Fogel H, Hallett M, Maidan I. TMS-evoked potentials unveil occipital network involvement in patients diagnosed with Parkinson's disease within 5 years of inclusion. NPJ Parkinsons Dis. 2024 Sep 30;10(1):182. doi: 10.1038/s41531-024-00793-0.
PubMed 39349492Lassman S, Zifman N, Fogel H, Hassin-Baer S, Anis S. TMS-evoked potentials provide novel neurophysiological features of Tourette syndrome. Parkinsonism Relat Disord. 2025 Jan;130:107217. doi: 10.1016/j.parkreldis.2024.107217. Epub 2024 Nov 22.
PubMed 39612660Maidan I, Zifman N, Hausdorff JM, Giladi N, Levy-Lamdan O, Mirelman A. A multimodal approach using TMS and EEG reveals neurophysiological changes in Parkinson's disease. Parkinsonism Relat Disord. 2021 Aug;89:28-33. doi: 10.1016/j.parkreldis.2021.06.018. Epub 2021 Jun 29.
PubMed 34216938
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials (TMS-EEG)
- ClinicalTrials.gov ID
- NCT06963775
- Acronym / sponsor ID
- (TMS-EEG) / 855370
- Conditions
- Traumatic Brain Injury
- Keywords
- TBI, Traumatic Brain Injury, TMS-EEG, neurological disorders
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 215 participants (estimated)
- Lead sponsor
- Ramon Diaz-ArrastiaUniversity, hospital or other
- Collaborators
- QuantalX Neuroscience
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 9 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumatic Brain Injury (Acute, Subacute, Chronic) | – | Device: Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel) |
| Healthy Control | – | Device: Delphi-MD device (QuantalX Neuroscience Ltd., Saba Israel) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age 18 years and older
- No history of TBI in the past 12 months
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Healthy Control, Traumatic Brain Injury (Acute, Subacute, Chronic) |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 33408607Levy-Lamdan O, Zifman N, Sasson E, Efrati S, Hack DC, Tanne D, Dolev I, Fogel H. Evaluation of White Matter Integrity Utilizing the DELPHI (TMS-EEG) System. Front Neurosci. 2020 Dec 21;14:589107. doi: 10.3389/fnins.2020.589107. eCollection 2020.
- Background: PubMed 34526957Fogel H, Levy-Lamdan O, Zifman N, Hiller T, Efrati S, Suzin G, Hack DC, Dolev I, Tanne D. Brain Network Integrity Changes in Subjective Cognitive Decline: A Possible Physiological Biomarker of Dementia. Front Neurol. 2021 Aug 30;12:699014. doi: 10.3389/fneur.2021.699014. eCollection 2021.
- Background: PubMed 31551761Zifman N, Levy-Lamdan O, Suzin G, Efrati S, Tanne D, Fogel H, Dolev I. Introducing a Novel Approach for Evaluation and Monitoring of Brain Health Across Life Span Using Direct Non-invasive Brain Network Electrophysiology. Front Aging Neurosci. 2019 Sep 9;11:248. doi: 10.3389/fnagi.2019.00248. eCollection 2019.
- Background: PubMed 39349492Zifman N, Levy-Lamdan O, Hiller T, Thaler A, Dolev I, Mirelman A, Fogel H, Hallett M, Maidan I. TMS-evoked potentials unveil occipital network involvement in patients diagnosed with Parkinson's disease within 5 years of inclusion. NPJ Parkinsons Dis. 2024 Sep 30;10(1):182. doi: 10.1038/s41531-024-00793-0.
- Background: PubMed 39612660Lassman S, Zifman N, Fogel H, Hassin-Baer S, Anis S. TMS-evoked potentials provide novel neurophysiological features of Tourette syndrome. Parkinsonism Relat Disord. 2025 Jan;130:107217. doi: 10.1016/j.parkreldis.2024.107217. Epub 2024 Nov 22.
- Background: PubMed 34216938Maidan I, Zifman N, Hausdorff JM, Giladi N, Levy-Lamdan O, Mirelman A. A multimodal approach using TMS and EEG reveals neurophysiological changes in Parkinson's disease. Parkinsonism Relat Disord. 2021 Aug;89:28-33. doi: 10.1016/j.parkreldis.2021.06.018. Epub 2021 Jun 29.
- Study deviceLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by Ramon Diaz-Arrastia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06963775, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.