- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03379220
Spreading Depolarizations in Traumatic Brain Injury
19. desember 2017 oppdatert av: Jed Hartings, University of Cincinnati
Development and Validation of Spreading Depolarization Monitoring for TBI Management
This research aims to extend the application of spreading depolarization monitoring to non-surgical TBI patients, using intraparenchymal electrode arrays and scalp electroencephalography to detect depolarizations and develop less invasive monitoring methods.
Studieoversikt
Status
Ukjent
Forhold
Detaljert beskrivelse
This study aims to develop the new clinical science of spreading depolarizations for routine monitoring of all TBI patients requiring intensive care.
This will be accomplished by investigating automated and non-invasive methods for bedside detection of spreading depolarizations and by determining the prognostic value of such monitoring across the spectrum of TBI severity.
While current monitoring of depolarizations is invasive and limited to the subgroup of TBI patients requiring craniotomy, pilot studies have shown that spreading depolarizations are also manifested in non-invasive scalp electroencephalographic (EEG) recordings.
Here, approximately 189 subjects will undergo neuromonitoring with EEG only (n=63), with combined EEG and intraparenchymal ECoG (n=63), or with combined EEG and subdural ECoG (n=63).
Simultaneous ECoG and EEG monitoring will allow characterization of the EEG signatures of spreading depolarizations and enable identification of signal-processing steps and quantitative criteria for their detection with clinically meaningful sensitivity and specificity, as validated against the gold standard of invasive ECoG.
In parallel, an observational electrophysiology study of all TBI patients admitted to intensive care, including non-surgical cases, will characterize the incidence of spreading depolarizations across the TBI severity spectrum.
Successful completion of these objectives will 1) determine the extent to which findings obtained in surgical TBI patients also generalize to patients who are managed medically, and 2) establish the first non-invasive method for routine bedside monitoring of a neuronal pathomechanism with proven relevance to TBI outcome.
In doing so, this study may enable an individualized approach to TBI management and clinical trials in which neuroprotective therapies can be administered selectively to patients based on real-time identification of a marker and mechanism of secondary neuronal injury.
Studietype
Observasjonsmessig
Registrering (Forventet)
189
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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San Francisco, California, Forente stater, 94110
- Rekruttering
- University of California San Francisco
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Ta kontakt med:
- Geoff T Manley, MD
- E-post: ManleyG@ucsf.edu
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Florida
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Miami, Florida, Forente stater, 33136
- Rekruttering
- University of Miami
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Ta kontakt med:
- Kristine H O'Phelan, MD
- E-post: kophelan@med.miami.edu
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Massachusetts
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Boston, Massachusetts, Forente stater, 02114
- Har ikke rekruttert ennå
- Massachusetts General Hospital
-
Ta kontakt med:
- Eric S Rosenthal, MD
- E-post: EROSENTHAL@mgh.harvard.edu
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Ohio
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Cincinnati, Ohio, Forente stater, 45267
- Rekruttering
- University of Cincinnati
-
Ta kontakt med:
- Laura B Ngwenya, MD, PhD
- E-post: ngwenyla@uc.edu
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Har ikke rekruttert ennå
- University of Pennsylvania
-
Ta kontakt med:
- Ramani Balu, MD, PhD
- E-post: Ramani.Balu@uphs.upenn.edu
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Pittsburgh, Pennsylvania, Forente stater, 15213
- Rekruttering
- University of Pittsburgh
-
Ta kontakt med:
- David O Okonkwo, MD, PhD
- E-post: okonkwodo@upmc.edu
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Texas
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Houston, Texas, Forente stater, 77030
- Rekruttering
- Baylor College of Medicine
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Ta kontakt med:
- Shankar P Gopinath, MD
- E-post: shankarg@bcm.edu
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
Approximately 189 patients admitted to intensive care for treatment of TBI will be enrolled.
The study will be conducted as an addition to TRACK-TBI (Transforming Research and Clinical Knowledge in Traumatic Brain Injury), an observational study conducted at 11 sites in the United States.
The present study will be implemented at 7 of the 11 sites: University of Cincinnati, University of Pennsylvania, University of Pittsburgh, University of Miami, Massachusetts General Hospital, University of California San Francisco, and Baylor College of Medicine.
Beskrivelse
Inclusion Criteria:
- Enrollment in TRACK-TBI CA cohort
- Admission to intensive care
- Documented TBI <24 hr before anticipated placement of electrodes
- Lobe of primary injury accessible for ECoG by burr hole or craniotomy access
- Age ≥ 18 years
- Acute brain CT for clinical care
- Visual acuity/hearing adequate for testing
- Fluency in English or Spanish
- Ability to obtain informed consent
Exclusion Criteria:
- Significant polytrauma that would confound outcome assessment
- Prisoners or patients in custody
- Pregnancy
- Patients on psychiatric hold
- Major debilitating baseline mental health disorder that would interfere with follow-up and the validity of outcome
- Major debilitating neurological disease impairing baseline awareness, cognition, or validity of follow-up and outcome assessment
- Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment
- Low likelihood of follow-up
- Current participation in an interventional trial
- Penetrating TBI
- Spinal cord injury with ASIA score of C or worse
- Bilateral unreactive pupils or other evidence of unsurvivable injury
- Evidence of coagulopathy (INR>1.5 or thrombocytopenia) or infection, which contraindicate invasive monitoring
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
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Subdural ECoG (Group 1)
For patients who require craniotomy to treat TBI, a subdural electrode strip will be placed intraoperatively following evacuation of a hematoma or contusion, as required.
Electrode strips will be used for subsequent electrocorticography (ECoG) during intensive care.
Patients will also undergo continuous scalp EEG monitoring.
|
Burr Hole ECoG (Group 2)
For patients who do not require surgery but do require invasive monitoring, an intraparenchymal ECoG electrode array will be placed through a cranial burr hole.
Depending on other monitoring needs, the location of injuries, and other clinical considerations, the burr hole may be the same as used for placement of other probes or may be separate.
In cases of focal injury, the burr hole will be placed to allow electrode targeting to a lobe with significant primary lesion(s).
Patients will also undergo continuous scalp EEG monitoring.
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EEG (Groups 1-3)
Continuous EEG recordings will be made using Ag/AgCl electrodes placed on or beneath the scalp (subdermal wire) according to standard practice.
The default montage will employ eight lead electrodes for each hemisphere following the 10/20 system (Right: Fp2, F4, C4, P4, O2, F8, T4, T6; left: Fp1, F3, C3, P3, O1, F7, T3, T5).
Other montages with more dense placement of electrodes in the region of ECoG monitoring may also be used.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Glasgow Outcome Scale Extended (GOS-E)
Tidsramme: 6 months following injury
|
Glasgow Outcome Scale- Extended (GOS-E) is an ordinal global scale for functional outcome that rates patient status into one of eight categories, with higher scores representing better recovery: Dead (1), Vegetative State (2), Lower Severe Disability (3), Upper Severe Disability (4), Lower Moderate Disability (5), Upper Moderate Disability (6), Lower Good Recovery (7), and Upper Good Recovery (8).
|
6 months following injury
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
28. mars 2017
Primær fullføring (Forventet)
31. desember 2019
Studiet fullført (Forventet)
14. juli 2020
Datoer for studieregistrering
Først innsendt
14. desember 2017
Først innsendt som oppfylte QC-kriteriene
14. desember 2017
Først lagt ut (Faktiske)
20. desember 2017
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. desember 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. desember 2017
Sist bekreftet
1. desember 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Hartings SD-II
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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