- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT03379220
Spreading Depolarizations in Traumatic Brain Injury
19 december 2017 uppdaterad 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.
Studieöversikt
Status
Okänd
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Förväntat)
189
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
-
San Francisco, California, Förenta staterna, 94110
- Rekrytering
- University of California San Francisco
-
Kontakt:
- Geoff T Manley, MD
- E-post: ManleyG@ucsf.edu
-
-
Florida
-
Miami, Florida, Förenta staterna, 33136
- Rekrytering
- University of Miami
-
Kontakt:
- Kristine H O'Phelan, MD
- E-post: kophelan@med.miami.edu
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02114
- Har inte rekryterat ännu
- Massachusetts General Hospital
-
Kontakt:
- Eric S Rosenthal, MD
- E-post: EROSENTHAL@mgh.harvard.edu
-
-
Ohio
-
Cincinnati, Ohio, Förenta staterna, 45267
- Rekrytering
- University of Cincinnati
-
Kontakt:
- Laura B Ngwenya, MD, PhD
- E-post: ngwenyla@uc.edu
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Förenta staterna, 19104
- Har inte rekryterat ännu
- University of Pennsylvania
-
Kontakt:
- Ramani Balu, MD, PhD
- E-post: Ramani.Balu@uphs.upenn.edu
-
Pittsburgh, Pennsylvania, Förenta staterna, 15213
- Rekrytering
- University of Pittsburgh
-
Kontakt:
- David O Okonkwo, MD, PhD
- E-post: okonkwodo@upmc.edu
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- Rekrytering
- Baylor College of Medicine
-
Kontakt:
- Shankar P Gopinath, MD
- E-post: shankarg@bcm.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Kohort
- Tidsperspektiv: Blivande
Kohorter och interventioner
Grupp / Kohort |
---|
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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Glasgow Outcome Scale Extended (GOS-E)
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
28 mars 2017
Primärt slutförande (Förväntat)
31 december 2019
Avslutad studie (Förväntat)
14 juli 2020
Studieregistreringsdatum
Först inskickad
14 december 2017
Först inskickad som uppfyllde QC-kriterierna
14 december 2017
Första postat (Faktisk)
20 december 2017
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
21 december 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
19 december 2017
Senast verifierad
1 december 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Hartings SD-II
Läkemedels- och apparatinformation, studiedokument
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Studerar en amerikansk FDA-reglerad produktprodukt
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produkt tillverkad i och exporterad från U.S.A.
Nej
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