- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00258505
Monitoring Brain Activity in Human Brain Injury
Incidence, Nature and Consequences of Cortical Depolarizations in Human Brain Injury From Trauma and Ischemia: The COSBID Study
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Cortical spreading depression (CSD) is a wave of mass neuronal firing and neuronal and glial depolarisation which propagates through grey matter in the central nervous system in response to a pathologic stimulus, at a rate of between 1 and 5 mm per minute. First described by Leão in 1944 as a sudden depression of ECoG amplitude spreading across the cortex of the rabbit (Leao, A. A. P. 1944), CSD can be elicited in experimental animals by chemical, electrical, and mechanical stimuli, with varying degrees of ease. CSD provoked in healthy, normally perfused neural tissue does not induce persistent metabolic stress or cellular damage, and indeed such induction of CSD in animal experiments may confer protection against the adverse effects of a subsequent ischaemic insult (Kobayashi, S. et al. 1995).
In animal models of focal cerebral ischaemia, usually induced by occlusion of the middle cerebral artery, a spontaneous phenomenon occurs around the periphery of the core territory, with electrophysiological features essentially identical with CSD, and similar capacity to propagate across cerebral cortex. Designated "peri-infarct depolarisation" (PID), this event is associated with infarct expansion, or recruitment of at-risk cortical territory into the expanding core, and has been shown capable of causing this expansion, in the absence of therapeutic intervention. Indeed it has been hypothesized that glutamate release may be involved in PID generation, and that excitotoxicity may accomplish detrimental effects via this route (Hossmann, K. A. 1994), (Obrenovitch, T. P. and Urenjak, J. 1997). Some experimental neuroprotection treatments for stroke act to decrease the incidence of PID (Iijima, T. et al. 1992;Chen, Q. et al. 1993;Busch, E. et al. 1996).
In traumatic and ischaemic (especially in middle cerebral artery occlusion and aneurysmal subarachnoid haemorrhage) brain injury in humans, a phase of delayed deterioration often associated with severe and refractory brain swelling develops between 2 and 5 days after the initial ictus, and is associated with poor or fatal outcome. The cause and mechanism of this deterioration remain poorly understood, and the possibility exists that CSD/PID events might contribute to deterioration.
To date, CSD or PID have been reported in only ten human subjects in two papers (Mayevsky, A. et al. 1996; Strong, A. J. et al. 2002). Strong et al. reported that transient ECoG suppressions suggestive of depolarisations are common - but by no means universal - after brain injury in humans. Sub-dural ECoG electrode strips were placed in 14 patients who had undergone craniotomy for trauma or intracranial hemorrhage; monitoring was for up to 60 h following the injury. Five of these patients (36%) showed patterns of ECoG depression consistent with PID/CSD in brain regions adjacent to the primary injury.
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Berlin, Deutschland
- Charité
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Beer-Sheva, Israel, 84101
- Soroka
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
Immediately following:
- traumatic brain injury
- aneurysmal subarachnoid haemorrhage or
- spontaneous intracerebral haematoma or
- stroke involving cerebral cortex
Exclusion Criteria:
- GCS = 3
- Bilateral fixed & dilated pupils or other evidence of massive irreversible brain injury
- more than 5 days post Injury/ictus.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Definierte Bevölkerung
- Zeitperspektiven: Interessent
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Jens Dreier, MD, Charite, Berlin, Germany
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienabschluss
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Ischämie
- Pathologische Prozesse
- Nekrose
- Herz-Kreislauf-Erkrankungen
- Gefäßerkrankungen
- Zerebrovaskuläre Erkrankungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Kraniozerebrales Trauma
- Trauma, Nervensystem
- Ischämie des Gehirns
- Streicheln
- Hirninfarkt
- Intrakranielle Blutungen
- Infarkt
- Hirnverletzungen
- Wunden und Verletzungen
- Blutung
- Hirnverletzungen, traumatisch
- Hirninfarkt
- Subarachnoidalblutung
- Hirnblutung
Andere Studien-ID-Nummern
- sor402605ctil
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