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

Noch nicht rekrutierend
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT06963775 ((TMS-EEG)) ist eine beobachtungsstudie zur Untersuchung von Traumatische Hirnverletzung und hat den Status noch nicht rekrutierend. Der Start ist für 1. März 2026 geplant, bis 215 Teilnehmer aufgenommen werden. Durchgeführt von Ramon Diaz-Arrastia wird der Abschluss für 31. Juli 2030 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 2. Oktober 2025 aktualisiert.
Kurzbeschreibung
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).
Offizieller Titel

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

Erkrankungen
Traumatische Hirnverletzung
Publikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:
Weitere Studien-IDs
  • (TMS-EEG)
  • 855370
NCT-Nummer
NCT06963775
Studienbeginn (tatsächlich)
2026-03-01
Zuletzt aktualisiert
2025-10-02
Studienende (vorauss.)
2030-07-31
Geplante Rekrutierung
215
Studientyp
Beobachtungsstudie
Status
Noch nicht rekrutierend
Stichwörter
TBI
Traumatic Brain Injury
TMS-EEG
neurological disorders
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
Traumatic Brain Injury (Acute, Subacute, Chronic)
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).
Healthy Control
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).
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
1. Differentiate between healthy controls and TBI participants in measured outputs of the DELPHI-MD device (WFA, STP, EPD, LPD, and Connectivity)
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
For single timepoint (day 1).
Day 1
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene, Ältere Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
Akzeptiert gesunde Freiwillige
Ja

  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.

  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).
Ramon Diaz-Arrastia logoRamon Diaz-Arrastia
QuantalX Neuroscience logoQuantalX Neuroscience
Verantwortliche Partei
Ramon Diaz-Arrastia, Prüfsponsor, Presidential Professor & Director of Clinical Traumatic Brain Injury Research Initiative, University of Pennsylvania Perelman School of Medicine
Zentrale Studienkontakte
Kontakt: TBIRI Research, 267-271-4951, [email protected]
1 Studienstandorte in 1 Ländern

Pennsylvania

University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States
TBIRI Research, Kontakt, 267-271-4951, [email protected]
Ramon Diaz-Arrastia, MD, PhD, Hauptprüfer